| 2026-01-07 | — | Spectral CT;
Product Code (REF): 728333; | |
| 2026-01-07 | — | Spectral CT 7500 on Rails;
Product Code (REF): 728334; | |
| 2026-01-07 | — | Brilliance iCT;
Product Code (REF): 728306; | |
| 2026-01-07 | — | IQon Spectral CT;
Product Code (REF): 728332; | |
| 2025-12-12 | — | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | |
| 2025-10-31 | — | IntelliVue MP70. Product Number: M8007A. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX100. Product Number: 867033. | |
| 2025-10-31 | — | IntelliVue MP50. Product Number: M8004A. | |
| 2025-10-31 | — | IntelliVue MP20. Product Number: M8001A. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX400. Product Number: 866060. | |
| 2025-10-31 | — | IntelliVue MP60. Product Number: M8005A. | |
| 2025-10-31 | — | IntelliVue Multi Measurement Server X2. Product Number: M3002A. | |
| 2025-10-31 | — | IntelliVue MP80. Product Number: M8008A. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX850. Product Number: 866470. | |
| 2025-10-31 | — | IntelliVue MP2. Product Number: M8102A. | |
| 2025-10-31 | — | IntelliVue MP30. Product Number: M8002A. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX500. Product Number: 866064. | |
| 2025-10-31 | — | IntelliVue Multi-Measurement Module X3. Product Number: 867030. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX600. Product Number: 865242. | |
| 2025-10-31 | — | IntelliVue MP90. Product Number: M8010A. | |
| 2025-10-31 | — | IntelliVue MP40. Product Number: M8003A. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX750. Product Number: 866471. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX800. Product Number: 865240. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX450. Product Number: 866062. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX550. Product Number: 866066. | |
| 2025-10-31 | — | IntelliVue Patient Monitor MX700. Product Number: 865241. | |
| 2025-10-31 | — | IntelliVue MP5. Product Number: M8105A. | |
| 2025-10-29 | — | CT 5300;
Software Version Number: 4.5, 5.0, 5.1; | |
| 2025-10-29 | — | Incisive CT;
Software Version Number: 4.5, 5.0, 5.1; | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Brilliance 16 Power, Model Number: 728240.
2. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Ingenuity CT 728326, Model Number: 728321.
2. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Brilliance iCT SP, Model Number: 728311. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Brilliance CT 40 Channel, Model Number: 728235.
| |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. CT 6000, Model Number: 728307. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Brilliance iCT, Model Number: 728306. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Big Bore RT, Model Number: 728242.
2. Brillia | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. IQon Spectral CT, Model Number: 728332. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Ingenuity CT Family Brazil, Model Number: 728325. | |
| 2025-08-13 | — | Philips CT systems labeled as the following:
1. Ingenuity Core128 / Elite China, Model Number: 72 | |
| 2025-05-29 | — | Spectral CT. Computed tomography X-ray system. | |
| 2025-05-13 | — | Product Name: Ingenia Ambition S;
Model Numbers: (1) 781359, (2) 782108, (3) 782139; | |
| 2025-05-13 | — | Product Name: Ingenia Elition S;
Model Numbers: (1) 781357, (2) 782106, (3) 782137; | |
| 2025-05-13 | — | Product Name: Ingenia 3.0T;
Model Numbers: (1) 781342, (2) 781377, (3) 782103; | |
| 2025-05-13 | — | Product Name: SmartPath to dStream for 1.5T;
Model Numbers: (1) 781260, (2) 782112, (3) 782146 | |
| 2025-05-13 | — | Product Name: Ingenia 1.5T CX;
Model Number: 781262; | |
| 2025-05-13 | — | Product Name: Evolution Upgrade 1.5T;
Model Numbers: (1) 782116, (2) 782148; | |
| 2025-05-13 | — | Product Name: Upgrade to MR 7700;
Model Number: 782130; | |
| 2025-05-13 | — | Product Name: Evolution Upgrade 3.0T;
Model Numbers: (1) 782117, (2) 782143; | |
| 2025-05-13 | — | Product Name: Ingenia Elition X;
Model Numbers: (1) 781358, (2) 782107, (3) 782136; | |
| 2025-05-13 | — | Product Name: SmartPath to dStream for XR and 3.0T;
Model Numbers: (1) 781270, (2) 782113; | |
| 2025-05-13 | — | Product Name: SmartPath to Ingenia Elition X;
Model Numbers: (1) 782118, (2) 782144; | |
| 2025-05-13 | — | Product Name: Ingenia 1.5T;
Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 7821 | |
| 2025-05-13 | — | Product Name: Ingenia Ambition X;
Model Numbers: (1) 781356, (2) 782109, (3) 782138; | |
| 2025-05-13 | — | Product Name: SmartPath to dStream for 3.0T;
Model Number: 782145 | |
| 2025-05-13 | — | Product Name: MR 7700;
Model Numbers: (1) 782120, (2) 782153; | |
| 2025-05-13 | — | Product Name: Ingenia 1.5T S;
Model Number: 781347; | |
| 2025-05-13 | — | Product Name: Ingenia 3.0T CX;
Model Number: 781271; | |
| 2025-05-13 | — | Product Name: MR 5300;
Model Numbers: (1) 782110, (2) 782152; | |
| 2025-04-07 | — | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line ST | |
| 2025-04-01 | — | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. | |
| 2025-03-10 | — | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | |
| 2025-03-10 | — | Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. | |
| 2025-02-25 | — | Zenition 50. Product Code 718096.
The devices are used for radiological guidance and visualization | |
| 2025-02-25 | — | Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization d | |
| 2025-02-25 | — | Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualizatio | |
| 2025-01-15 | — | IntelliBridge EC10 Module. Model Number: 865115 | |
| 2025-01-15 | — | IntelliVue Patient Monitor MX500. Model Number: 866064 | |
| 2025-01-15 | — | IntelliVue Patient Monitor MX450. Model Number: 866062 | |
| 2025-01-15 | — | IntelliVue Patient Monitor MX550. Model Number: 866066 | |
| 2025-01-15 | — | IntelliVue Patient Monitor MX400. Model Number: 866060 | |
| 2024-11-20 | — | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | |
| 2024-11-16 | — | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | |
| 2024-11-04 | — | Mammotrak Diagnostic Coil 3.0T | |
| 2024-11-04 | — | dS Breast 7ch 1.5T | |
| 2024-11-04 | — | SENSE Breast Coil 3.0T 7ch | |
| 2024-11-04 | — | dS Breast 7ch 3.0T | |
| 2024-11-04 | — | Mammotrak Interventional Coil 3.0T | |
| 2024-11-04 | — | Achieva TX Interventional Coil 3.0T | |
| 2024-11-04 | — | SENSE Breast Coil | |
| 2024-11-04 | — | Mammotrak Interventional Coil 1.5T | |
| 2024-11-04 | — | Mammotrak Diagnostic Coil 1.5T | |
| 2024-11-04 | — | dS Breast 16ch 3.0T | |
| 2024-11-04 | — | ST SENSE Breast Dx Coil | |
| 2024-11-04 | — | ST SENSE Breast Coil | |
| 2024-11-04 | — | dS Breast 16ch 1.5T | |
| 2024-09-03 | — | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional imag | |
| 2024-09-03 | — | MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/ | |
| 2024-09-03 | — | SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spe | |
| 2024-09-03 | — | Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic ima | |
| 2024-09-03 | — | Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic | |
| 2024-09-03 | — | Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images | |
| 2024-09-03 | — | Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images | |
| 2024-09-03 | — | Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im | |
| 2024-09-03 | — | Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic im | |
| 2024-09-03 | — | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectrosco | |
| 2024-09-03 | — | Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic | |
| 2024-09-03 | — | MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/ | |
| 2024-09-03 | — | SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, sp | |
| 2024-06-28 | — | IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements
Model Number: | |
| 2024-06-28 | — | IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements
Model Number: | |
| 2024-06-28 | — | IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements
Model Number: | |
| 2024-06-28 | — | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements
Model Number: | |
| 2024-06-05 | — | SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR I | |
| 2024-06-05 | — | SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips | |
| 2024-06-05 | — | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR I | |
| 2024-05-22 | — | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and external | |
| 2024-05-03 | — | MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diag | |
| 2024-05-03 | — | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a | |
| 2024-05-03 | — | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a dia | |
| 2024-05-03 | — | Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a | |
| 2024-05-03 | — | Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a | |
| 2024-05-03 | — | Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo | |
| 2024-05-03 | — | Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use | |
| 2024-05-03 | — | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems | |
| 2024-05-03 | — | Achieva 3.0T
Model Number (REF):
(1) 781345;
(2) 781344;
(3) 781278;
(4) 781277;
(5) 781177 | |
| 2024-05-03 | — | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a | |
| 2024-05-03 | — | Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for u | |
| 2024-05-03 | — | MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as | |
| 2024-05-03 | — | Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use | |
| 2024-05-03 | — | Ingenia 1.5T S
Model Number (REF):
781347 | |
| 2024-05-03 | — | Achieva 3.0T TX for PET
Model Number (REF): 781479 | |
| 2024-05-03 | — | Evolution upgrade 3.0T
Model Number (REF):
(1)782117;
(2) 782143 | |
| 2024-05-03 | — | Ingenia 3.0T CX
Model Number (REF):
(1) 782105
(2) 781271 | |
| 2024-05-03 | — | Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a | |
| 2024-05-03 | — | MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for | |
| 2024-05-03 | — | Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo | |
| 2024-05-03 | — | Ingenia 1.5T
Model Number (REF):
(1) 782140;
(2) 782115;
(3) 782101;
(4) 781396;
(5) 781341;
(6) 78 | |
| 2024-05-03 | — | SmartPath to dStream for 3.0T
Model Number (REF): 782145 | |
| 2024-05-03 | — | MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagno | |
| 2024-05-03 | — | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indica | |
| 2024-05-03 | — | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indi | |
| 2024-05-03 | — | Achieva 1.5T Initial system
Model Number (REF): 781178 | |
| 2024-05-03 | — | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use | |
| 2024-05-03 | — | HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to | |
| 2024-05-03 | — | HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to th | |
| 2024-05-03 | — | Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo | |
| 2024-05-03 | — | Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d | |
| 2024-05-03 | — | Ingenia Ambition S
Model Number (REF):
(1) 782139;
(2) 782133;
(3) 782108;
(4) 781359 | |
| 2024-05-03 | — | HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to th | |
| 2024-04-22 | — | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical | |
| 2024-04-22 | — | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Sy | |
| 2024-04-19 | — | Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. | |
| 2024-04-15 | — | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the bod | |
| 2024-04-15 | — | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the bod | |
| 2024-03-29 | — | The Oncology Essentials Package of the Spectral CT imaging system. | |
| 2024-03-22 | — | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):
1. APC (Schneider El | |
| 2024-03-12 | — | Intera 1.5T Master/Nova, Magnetic Resonance System. | |
| 2024-03-12 | — | MR 5300, Magnetic Resonance System. | |
| 2024-03-12 | — | GYROSCAN ACS-NT, Magnetic Resonance System. | |
| 2024-03-12 | — | SmartPath to dStream for 1.5T, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia Ambition S, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia 1.5T, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva 1.5T Conversion, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia Elition S, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 3.0T Quasar Dual, Magnetic Resonance System. | |
| 2024-03-12 | — | GYROSCAN T10-NT, Magnetic Resonance System. | |
| 2024-03-12 | — | Enterprise 1.5T, Magnetic Resonance System. | |
| 2024-03-12 | — | MR 7700, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 0.5T Standard, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T Achieva Nova, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T R11, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia Ambition X, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva 3.0T, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T Achieva IT Nova, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia 3.0T, Magnetic Resonance System. | |
| 2024-03-12 | — | SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva 1.5T, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T Power/Pulsar, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia 1.5T CX, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva 3.0T for PET, Magnetic Resonance System. | |
| 2024-03-12 | — | GYROSCAN T5, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva XR, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera CV, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia 1.5T S, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T Omni/Stellar, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.0T Power/Pulsar, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva 3.0TX for PET, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia Elition X, Magnetic Resonance System. | |
| 2024-03-12 | — | GYROSCAN T5-NT, Magnetic Resonance System. | |
| 2024-03-12 | — | Achieva 1.5T Initial, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera Achieva 1.5T Pulsar, Magnetic Resonance System. | |
| 2024-03-12 | — | Ingenia 3.0T CX, Magnetic Resonance System. | |
| 2024-03-12 | — | Evolution Upgrade 3.0T, Magnetic Resonance System. | |
| 2024-03-12 | — | Intera 1.0T Omni/Stellar, Magnetic Resonance System. | |
| 2024-02-15 | — | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central
monitoring s | |
| 2023-11-30 | — | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | |
| 2023-11-17 | — | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic | |
| 2023-10-23 | — | Achieva 1.5T Conversion | |
| 2023-10-23 | — | Intera 1.5T | |
| 2023-10-23 | — | Ingenia 1.5T CX | |
| 2023-10-23 | — | Achieva 1.5T Initial System | |
| 2023-10-23 | — | Intera 1.5T Power/Pulsar | |
| 2023-10-23 | — | Achieva 1.5T | |
| 2023-10-23 | — | SmartPath to dStream for 1.5T | |
| 2023-10-09 | — | Big Bore RT with software version V4.8.0.10421- Model: 728242
CT scanner and simulator designed fo | |
| 2023-10-09 | — | Brilliance CT Big Bore with software version V4.8.0.10421
Model:728244
CT scanner and simulator des | |
| 2023-10-09 | — | Brilliance CT Big Bore Oncology with software version V4.8.0.10421
Model:728243
CT scanner and simu | |
| 2023-09-21 | — | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system | |
| 2023-09-21 | — | DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiograph | |
| 2023-09-21 | — | DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radi | |
| 2023-09-21 | — | DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radio | |
| 2023-09-21 | — | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiogr | |
| 2023-09-21 | — | DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital ra | |
| 2023-09-21 | — | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | |
| 2023-09-21 | — | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital | |
| 2023-09-21 | — | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radio | |
| 2023-09-21 | — | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiograp | |
| 2023-08-31 | — | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo R | |
| 2023-08-31 | — | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Ma | |
| 2023-08-17 | — | Patient Information Center iX with Software Version Number 4.x in the following:
(1) Patient Inform | |
| 2023-06-14 | — | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Op | |
| 2023-05-19 | — | DigitalDiagnost C90, Model No. 712034 and 712035 | |
| 2023-03-17 | — | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | |
| 2023-03-09 | — | Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy
Mod | |
| 2023-03-09 | — | DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy
Model Nu | |
| 2023-03-06 | — | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01
Product Number: 863359 | |
| 2023-03-06 | — | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01
Product Number: 863380 | |
| 2022-11-22 | — | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 | |
| 2022-11-22 | — | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | |
| 2022-11-22 | — | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 | |
| 2022-11-22 | — | Philips Upgrade to MR 7700 System, Model Number 782130 | |
| 2022-11-22 | — | Philips MR 7700 System, Model Number 782120 | |
| 2022-11-21 | — | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during la | |
| 2022-10-21 | — | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-func | |
| 2022-09-06 | — | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561
This is a component of produc | |
| 2022-03-29 | — | The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by | |
| 2022-02-25 | — | DigitalDiagnost C50 1.1 | |
| 2022-02-22 | — | Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. F | |
| 2022-02-07 | — | The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for | |
| 2022-02-04 | — | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS | |
| 2022-02-04 | — | Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YE | |
| 2022-02-02 | — | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Az | |
| 2022-01-03 | — | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager ver | |
| 2021-11-29 | — | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | |
| 2021-11-29 | — | Heel Snuggler, Reference # 989805603411 99047 | |
| 2021-11-29 | — | Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T | |
| 2021-11-29 | — | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 | |
| 2021-11-26 | — | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | |
| 2021-11-24 | — | Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without a | |
| 2021-11-24 | — | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System produc | |
| 2021-11-19 | — | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovasc | |
| 2021-11-12 | — | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration st | |
| 2021-11-12 | — | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. .
Mo | |
| 2021-11-12 | — | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system | |
| 2021-11-12 | — | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system | |
| 2021-10-29 | — | Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluorosco | |
| 2021-10-21 | — | ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110 | |
| 2021-10-21 | — | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 | |
| 2021-09-24 | — | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 7220 | |
| 2021-08-13 | — | The Azurion series (within the limits of the used Operation Room table) are intended for use to perf | |
| 2021-08-13 | — | The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular a | |
| 2021-08-13 | — | The Allura Xper series is intended for use on human patients to perform:
"Vascular, cardiovascular a | |
| 2021-08-11 | — | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic | |
| 2021-08-11 | — | Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic | |
| 2021-08-11 | — | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic de | |
| 2021-08-11 | — | SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for u | |
| 2021-08-11 | — | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagno | |
| 2021-08-11 | — | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic devi | |
| 2021-08-11 | — | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic | |
| 2021-08-11 | — | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic devic | |
| 2021-08-11 | — | Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic de | |
| 2021-08-11 | — | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic dev | |
| 2021-08-11 | — | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a | |
| 2021-08-11 | — | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic | |
| 2021-07-30 | — | Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic devi | |
| 2021-07-30 | — | Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnost | |
| 2021-07-30 | — | Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. | |
| 2021-07-30 | — | Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic de | |
| 2021-07-30 | — | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. | |
| 2021-07-30 | — | Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic de | |
| 2021-07-30 | — | Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. | |
| 2021-07-16 | — | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, | |
| 2021-06-08 | — | 728332 IQon Spectral CT-Computed Tomography X-ray system | |
| 2021-06-08 | — | 728306 Brilliance iCT-Computed Tomography X-ray systems
728305 Brilliance iCT Upgrades | |
| 2021-06-08 | — | Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system | |
| 2021-06-08 | — | 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system | |
| 2021-06-08 | — | 728333 Spectral CT 7500 -Computed Tomography X-ray system | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice
System Numbe | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728333 - Spectral CT: | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882446 - Vereos PET/CT | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64
System Number: 8824 | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT
System | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728332 - IQon Spectral | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16
System Number: 88 | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882442/882456 - Ingenuit | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
Ingenuity Core, Ingenuit | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728306 - Brilliance iCT | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT
System Number | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882476 - Gemini TF Big | |
| 2021-05-01 | — | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use | |
| 2021-04-23 | — | Ingenia Ambition X - Model Number: 781356,
Diagnostic MR system.
***Updated November 2023*** Added | |
| 2021-04-23 | — | Ingenia Ambition S - Model Number: 781359
Diagnostic MR system. | |
| 2021-04-13 | — | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head | |
| 2021-03-29 | — | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for | |
| 2021-03-23 | — | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and a | |
| 2021-02-22 | — | Incisive CT Computed Tomography X-ray System
Model: 728143 | |
| 2021-02-09 | — | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A | |
| 2021-02-09 | — | Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 | |
| 2021-02-09 | — | Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A | |
| 2021-02-09 | — | Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A | |
| 2021-02-02 | — | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06 | |
| 2020-11-19 | — | Emission Computed Tomography System Image Process System - Product Usage: intended for general Nucle | |
| 2020-11-18 | — | Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and record | |
| 2020-11-18 | — | Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monito | |
| 2020-09-14 | — | Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742 | |
| 2020-09-14 | — | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, | |
| 2020-07-16 | — | Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M | |
| 2020-06-30 | — | IntelliVue MX700 patient monitor, model no. 865241 | |
| 2020-06-30 | — | IntelliVue MX800 patient monitor, model no. 865240 | |
| 2020-06-25 | — | IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 4535 | |
| 2020-06-18 | — | Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the | |
| 2020-06-18 | — | Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in | |
| 2020-06-18 | — | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery | |
| 2020-06-08 | — | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monit | |
| 2020-06-02 | — | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. | |
| 2020-05-19 | — | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patien | |
| 2020-04-27 | — | Philips HeartStart MRx Monitor/Defibrillators
Model numbers M3535A, M3536A, and M3536M - Product Us | |
| 2020-04-23 | — | ProxiDiagnost N90, UDI 706100 | |
| 2020-04-21 | — | Philips HeartStart XL Monitor/Defibrillators
Model number: M4735A - Product Usage: is for use in the | |
| 2020-04-20 | — | Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compa | |
| 2020-04-13 | — | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to | |
| 2020-04-13 | — | Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also | |
| 2020-04-13 | — | Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the | |
| 2020-04-10 | — | Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guida | |
| 2020-04-10 | — | HeartStart MRx Processor Board PCA Replacement Kits
453563478461, a component of the Philips HeartSt | |
| 2020-04-10 | — | Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guida | |
| 2020-04-07 | — | Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: gene | |
| 2020-04-06 | — | Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)008 | |
| 2020-04-06 | — | Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 | |
| 2020-04-06 | — | Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(2 | |
| 2020-04-03 | — | Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the | |
| 2020-03-05 | — | TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System
Codes 453564007261, 453 | |
| 2020-03-05 | — | TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 45 | |
| 2020-03-05 | — | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079
Image guidance in diagnostic, interve | |
| 2020-02-26 | — | HeartStart MRx Monitor/Defibrillators with model numbers M3535A
M3536A, M3536M, M3536MC, M3536M2, M3 | |
| 2020-02-20 | — | Expression MR400 MRI Patient Monitoring System
Model Number: 866185
Software version number: 01.03. | |
| 2020-01-14 | — | Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/D | |
| 2020-01-13 | — | Philips DigiTrak XT Holter Recorder Software version number
B.1 and C.2.
The DigiTrak XT Recorder is | |
| 2019-12-30 | — | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044) | |
| 2019-12-30 | — | Allura CV20, system code 722031 | |
| 2019-12-30 | — | Poly G Integris H5000, System code 72246 | |
| 2019-12-30 | — | Integris Allura 9, system codes 722018
722021 | |
| 2019-12-30 | — | UroDiagnost Eleva, system code 708033 | |
| 2019-12-30 | — | OmniDiagnost Eleva System codes 708028
708027 | |
| 2019-12-30 | — | MultiDiagnost Eleva, System codes 722030
722016
722017
708032
708036
708034
708037
708038 | |
| 2019-12-30 | — | Cardio Vascular-Allura Centron, system code 722400 | |
| 2019-12-30 | — | Allura Exper FD Series. System codes
722003
722010
722022
722005
722011
722019
722001
722002
722006
| |
| 2019-12-23 | — | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and | |
| 2019-11-20 | — | ProxiDiagnost N90 | |
| 2019-10-16 | — | HeartStart XL+ Defibrillator/Monitor, Model 861290 | |
| 2019-10-03 | — | HeartStart XL+ Defibrillator/Monitor, Model 861290 | |
| 2019-09-10 | — | Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI code | |
| 2019-09-10 | — | Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 | |
| 2019-08-23 | — | IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot | |
| 2019-07-19 | — | Philips 5-Lead Set, Disposable, Bedside, AAMI
Model # 989803173131
Product Usage:
Philips Single-Pa | |
| 2019-07-16 | — | HeartStart MRx Monitor/Defibrillator
Model # M3535A - Product Usage: The HeartStart MRx is a lightwe | |
| 2019-07-16 | — | Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as fo | |
| 2019-06-07 | — | Philips HeartStart MRx devices in use with the M3539A AC Power Module:
M3535A, M3536A, M3536M, M3536 | |
| 2019-04-29 | — | Philips Patient Information Center iX configured with a regional setting which uses a comma for a de | |
| 2019-04-29 | — | Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal sep | |
| 2019-04-19 | — | SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological paramet | |
| 2019-04-19 | — | SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters | |
| 2019-04-19 | — | SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of pati | |
| 2019-04-19 | — | SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patie | |
| 2019-04-19 | — | SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of pati | |
| 2019-04-19 | — | SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of | |
| 2019-04-19 | — | SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters o | |
| 2019-04-19 | — | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients ( | |
| 2019-03-28 | — | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 | |
| 2019-03-28 | — | IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All:
453564711531 and 453564 | |
| 2019-03-28 | — | IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers
All other countries: 4535644 | |
| 2019-03-28 | — | IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262 | |
| 2019-03-12 | — | Azurion FlexArm, 722079 | |
| 2019-02-28 | — | Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025
Product Usage:
The Philips OmniDi | |
| 2019-02-28 | — | MultiDiagnost-Eleva, Product codes 708032, 708036
Product Usage:
As a multifunctional I universal i | |
| 2019-02-28 | — | Urodiagnost, Product No. 708033
Product Usage:
The Philips UroDiagnost MRF can be used to perform a | |
| 2019-02-28 | — | MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038
Product Usage:
As a mult | |
| 2019-02-28 | — | URODiagnost Eleva, Product codes 708026, 708027, 708028
Product Usage:
The Philips OmniDiagnost is | |
| 2019-01-25 | — | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product | |
| 2019-01-25 | — | Fetal Spiral Electrode, Model No. 9898 031 37631 | |
| 2019-01-09 | — | PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate | |
| 2019-01-09 | — | PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate | |
| 2019-01-09 | — | PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the e | |
| 2019-01-09 | — | PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and includin | |
| 2019-01-09 | — | PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including | |
| 2019-01-09 | — | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and includin | |
| 2019-01-09 | — | PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including | |
| 2019-01-09 | — | PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the e | |
| 2019-01-09 | — | PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 | |
| 2018-11-23 | — | HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of Hear | |
| 2018-08-08 | — | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 | |
| 2017-07-12 | — | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969
Product Usage:
The Hear | |
| 2017-02-24 | — | HeartStart MRx Monitor/Defibrillator,
Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3 | |