| 2026-03-19 | — | Philips AneurysmFlow. Model Number: 001015.
AneurysmFlow is a software medical device (Interventio | |
| 2026-03-05 | — | Vue Motion V12. Product Number: 1017979. | |
| 2026-01-26 | — | Azurion 5 M12
System Model Numbers: (1)722227, (2)722231;
Software Version Number - All versions: R1 | |
| 2026-01-26 | — | Azurion 3 M15
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only);
Softwar | |
| 2026-01-26 | — | Azurion 3 M12
System Model Numbers: (1) 722063, (2) 722221, (3) 722229;
Software Version Number - Al | |
| 2026-01-26 | — | Azurion 7 B20
System Model Numbers: (1)722068, (2)722226, (3)722236;
Software Version Number - All v | |
| 2026-01-26 | — | Azurion 7 M20
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only);
Software V | |
| 2026-01-26 | — | Azurion 7 B12
System Model Numbers:(1) 722067, (2) 722225, (3) 722235;
Software Version Number - All | |
| 2026-01-26 | — | Azurion 7 M12
System Model Numbers: (1)722078, (2)722223, (3)722233;
Software Version Number - All v | |
| 2026-01-26 | — | Azurion 5 M20
System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only);
Software Version Numb | |
| 2025-12-15 | — | Allura Xper FD10F;
Model Number: 722002; | |
| 2025-12-15 | — | Allura Xper FD10/10;
Model Number: 722005; | |
| 2025-12-15 | — | Allura Xper FD20;
Model Number: 722028; | |
| 2025-12-15 | — | Allura Xper FD20 Biplane;
Model Number: 722013; | |
| 2025-12-15 | — | Allura Xper FD20/20;
Model Number: 722038; | |
| 2025-12-15 | — | Allura Xper FD10;
Model Number: 722003; | |
| 2025-12-15 | — | Allura Xper FD10/10;
Model Number: 722027; | |
| 2025-12-15 | — | Product Name: Allura Xper FD10C;
Model number: 722001; | |
| 2025-12-15 | — | Allura Xper FD20/10;
Model Number: 722029; | |
| 2025-12-15 | — | Allura Xper FD20;
Model Number: 722006; | |
| 2025-12-15 | — | Allura Xper FD20 OR Table;
Model Number: 722023; | |
| 2025-12-15 | — | Allura Xper FD10;
Model Number: 722010; | |
| 2025-12-15 | — | Allura Xper FD20 Biplane;
Model Number: 722008; | |
| 2025-12-15 | — | Allura Xper FD10/10;
Model Number: 722011; | |
| 2025-12-15 | — | Allura Xper FD10;
Model Number: 722026; | |
| 2025-12-15 | — | Allura Xper FD20;
Model Number: 722012; | |
| 2025-12-12 | — | Philips Azurion system; Software Version Number: R3.1; | |
| 2025-12-12 | — | Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label des | |
| 2025-12-08 | — | Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:
1 | |
| 2025-10-02 | — | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system.
Model Number: 722234; | |
| 2025-09-29 | — | Zenition 50;
Product Number (REF): 718096; Interventional fluoroscopic x-ray system | |
| 2025-09-03 | — | Allura Xper FD10;
Model Numbers: (1) 722003, (2) 722010, (3) 722026;
Associated 510(k)s: K102005, | |
| 2025-09-03 | — | Allura Xper FD20/20;
Model Numbers: 722038;
Associated 510(k)s: K102005, K130638, K130842, K133292 | |
| 2025-09-03 | — | Allura Xper FD20
Product Codes: (1)722012, (2) 722028, (3) 722006;
Associated 510(k) numbers: K10200 | |
| 2025-09-03 | — | Allura Xper FD20 OR Table
Product Codes: (1)722023, (2) 722035, (3) 722015;
Associated 510(k) number | |
| 2025-09-03 | — | Allura Xper FD20 Biplane OR Table;
Model Numbers: (1) 722020, (2) 722025;
Associated 510(k)s: K102 | |
| 2025-09-03 | — | Allura Xper FD20/15 OR Table;
Model Numbers: 722059;
Associated 510(k)s: K102005, K130638, K130842 | |
| 2025-09-03 | — | Allura Xper FD10 OR Table
Product Codes: (1)722022, (2) 722033;
Associated 510(k) numbers: K102005, | |
| 2025-09-03 | — | Allura Xper FD20/10;
Model Numbers: 722029;
Associated 510(k)s: K102005, K130638, K130842, K133292 | |
| 2025-09-03 | — | Cardio Vascular-Allura Centron;
Model Numbers: 722400;
Associated 510(k)s: K102005, K130638, K1308 | |
| 2025-09-03 | — | Allura Xper FD20/20;
Product Code: 722038;
Associated 510(k) numbers: K102005, K130842, K130638, K13 | |
| 2025-09-03 | — | Allura Xper FD10C;
Model Number: 722001;
Associated 510(k)s: K102005, K130638, K130842, K133292, K | |
| 2025-09-03 | — | Allura CV20;
Product Code: 722031;
Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1 | |
| 2025-09-03 | — | Allura Xper FD20/20 OR Table;
Model Numbers: 722039;
Associated 510(k)s: K102005, K130638, K130842 | |
| 2025-09-03 | — | Allura Xper FD10/10;
Model Numbers: (1) 722005, (2) 722011, (3) 722027;
Associated 510(k)s: K10200 | |
| 2025-09-03 | — | Allura Xper FD20/15;
Model Numbers: 722058;
Associated 510(k)s: K102005, K130638, K130842, K133292 | |
| 2025-09-03 | — | Allura Xper FD20 Biplane OR Table
Product Codes: (1)722020, (2) 722025;
Associated 510(k) numbers: K | |
| 2025-09-03 | — | Allura Xper FD20/10;
Product Code: 722029;
Associated 510(k) numbers: K102005, K130842, K130638, K13 | |
| 2025-09-03 | — | Allura Xper FD10
Product Codes: (1)722010, (2) 722026, (3) 722003;
Associated 510(k) numbers: K10200 | |
| 2025-09-03 | — | Allura Xper FD10/10
Product Codes: (1)722011, (2) 722027, (3) 722005;
Associated 510(k) numbers: K10 | |
| 2025-09-03 | — | Allura Xper FD20/20 OR Table;
Product Code: 722039;
Associated 510(k) numbers: K102005, K130842, K13 | |
| 2025-09-03 | — | Allura Xper FD20/15;
Product Code: 722058;
Associated 510(k) numbers: K102005, K130842, K130638, K13 | |
| 2025-09-03 | — | Allura Xper CV20;
Model Numbers: 722031;
Associated 510(k)s: K102005, K130638, K130842, K133292, K | |
| 2025-09-03 | — | Allura Xper FD20 OR Table;
Model Numbers: (1) 722015, (2) 722023, (3) 722035;
Associated 510(k)s: | |
| 2025-09-03 | — | Allura Xper FD20 Biplane;
Model Numbers: (1) 722008, (2) 722013;
Associated 510(k)s: K102005, K130 | |
| 2025-09-03 | — | Allura Xper FD10 OR Table;
Model Numbers: 722033;
Associated 510(k)s: K102005, K130638, K130842, K | |
| 2025-09-03 | — | Allura Xper FD20;
Model Numbers: (1) 722006, (2) 722012, (3) 722028;
Associated 510(k)s: K102005, | |
| 2025-09-03 | — | Allura Xper FD20/15 OR Table;
Product Code: 722059;
Associated 510(k) numbers: K102005, K130842, K13 | |
| 2025-09-03 | — | Allura Xper FD20 Biplane
Product Codes: (1)722013, (2) 722008;
Associated 510(k) numbers: K102005, K | |
| 2025-08-01 | — | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with | |
| 2025-08-01 | — | Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the fo | |
| 2025-08-01 | — | Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x).
Labeled as the | |
| 2025-06-30 | — | Philips Allura R8.2.x Systems. Software Verion: R8.2.x.
1. Allura Xper FD10, Model Number: 72202 | |
| 2025-06-04 | — | Azurion 7 M20. Fluoroscopic X-Ray System. | |
| 2025-05-28 | — | Azurion R1.x and R2.x systems;
Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 7 | |
| 2025-03-24 | — | Intera 1.5T R11, Model Number: 781170; | |
| 2025-03-24 | — | Intera CV, Model Number: 781107; | |
| 2025-03-24 | — | SmartPath to dStream for 1.5T, Model Number: 782146; | |
| 2025-03-24 | — | Intera 1.5T Omni/Stellar, Model Number: 781104; | |
| 2025-03-24 | — | Enterprise 1.5T, Model Number: 781145; | |
| 2025-03-24 | — | Intera 1.5T Power/Pulsar, Model Number: 781105; | |
| 2025-03-24 | — | SmartPath to dStream for 3.0T, Model Number: 782145; | |
| 2025-03-24 | — | Intera 3.0T Quasar Dual, Model Number: 781150; | |
| 2025-03-24 | — | Intera 1.5T Master/Nova, Model Number: 781106; | |
| 2025-03-24 | — | Intera 1.0T Omni/Stellar, Model Number: 781102; | |
| 2025-03-24 | — | Intera 1.5T Explorer/Nova Dual, Model Number: 781108; | |
| 2025-03-24 | — | Intera 1.5T, Model Numbers: 781195 and 781295; | |
| 2025-03-24 | — | Intera 1.0T Power/Pulsar, Model Number: 781103; | |
| 2025-03-24 | — | Intera 0.5T Standard, Model Number: 781101; | |
| 2025-01-13 | — | Azurion 5 M20
System Code:
(1) 722228
(2) 722232
(3) 722281 | |
| 2025-01-13 | — | Allura Xper FD20/20; Catalog numbers: 722038 | |
| 2025-01-13 | — | Azurion 7 M20
System code:
(1) 722224
(2) 722079
(3) 722234
(4) 722282
System Code:
(1) | |
| 2025-01-13 | — | Azurion 7 B12
System Code:
(1) 722067
(2) 722225
(3) 722235 | |
| 2025-01-13 | — | Allura Xper FD10C
System Code:
(1) 722001 | |
| 2025-01-13 | — | Allura Xper FD20/20
System Code:
(1) 722038 | |
| 2025-01-13 | — | Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. | |
| 2025-01-13 | — | Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. | |
| 2025-01-13 | — | Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. | |
| 2025-01-13 | — | Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); | |
| 2025-01-13 | — | Allura Xper FD10 -
Catalog numbers: (1) 722003, (2) 722010, (3) 722026, | |
| 2025-01-13 | — | AlluraXper FD20 Biplane OR Table
System Code:
(1) 722020
(2) 722025 | |
| 2025-01-13 | — | Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). | |
| 2025-01-13 | — | Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. | |
| 2025-01-13 | — | Allura Xper FD20/10; Catalog numbers: 722029 | |
| 2025-01-13 | — | AlluraXper FD20
System Code:
(1) 722006
(2) 722012
(3) 722028 | |
| 2025-01-13 | — | Allura Xper FD10
Catalog
(1) 722003
(2) 722010
(3)722026 | |
| 2025-01-13 | — | Azurion 3 M12
System Code:
(1) 722063
(2) 722221 | |
| 2025-01-13 | — | Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). | |
| 2025-01-13 | — | Azurion 7 M12
System Code:
(1) 722078
(2) 722223
(3) 722233 | |
| 2025-01-13 | — | AlluraXper FD20 Biplane
System Code:
(1) 722008
(2) 722013 | |
| 2025-01-13 | — | Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. | |
| 2025-01-13 | — | Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. | |
| 2025-01-13 | — | Allura Xper FD10C; Catalog number: 722001 | |
| 2025-01-13 | — | AlluraXperFD20/10
System Code:
(1) 722029 | |
| 2025-01-13 | — | Azurion 3 M15
System Code:
(1) 722064
(2) 722222
(3) 722280 | |
| 2025-01-13 | — | Allura CV20
System Code: 722031 | |
| 2025-01-13 | — | Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). | |
| 2025-01-13 | — | Allura Xper FD20/15; Catalog numbers: 722058 | |
| 2025-01-13 | — | Allura CV20; Catalog numbers: 722031 | |
| 2025-01-13 | — | Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). | |
| 2025-01-13 | — | Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. | |
| 2025-01-13 | — | AlluraXperFD20/15
System Code:
(1) 722058 | |
| 2025-01-13 | — | AlluraXper FD10/10
System Code:
(1) 722005
(2) 722011
(3) 722027 | |
| 2025-01-13 | — | Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). | |
| 2025-01-13 | — | Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). | |
| 2025-01-13 | — | AlluraXper FD20 OR Table
System Code:
(1) 722023
(2) 722035 | |
| 2025-01-13 | — | Azurion 7 B20
System Code:
(1) 722068
(2) 722226
(3) 722236 | |
| 2025-01-13 | — | Azurion 5 M12
System Code:
(1) 722227
(2) 722231 | |
| 2024-11-11 | — | Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following:
1. Allura Xper FD10, Model Nu | |
| 2024-10-07 | — | Philips Zenition 50, Model Number: 718096 | |
| 2024-10-07 | — | Philips Zenition 70, Model Number: 718133 | |
| 2024-08-22 | — | System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/ | |
| 2024-08-22 | — | System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 7 | |
| 2024-08-22 | — | System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Dete | |
| 2024-08-22 | — | System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B1 | |
| 2024-08-08 | — | Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model | |
| 2024-08-06 | — | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray | |
| 2024-07-15 | — | Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number:
R1.0, R1.1, R | |
| 2024-05-16 | — | Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Versio | |
| 2024-05-16 | — | Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Softwar | |
| 2024-05-16 | — | Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Versio | |
| 2024-05-02 | — | Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasi | |
| 2024-02-06 | — | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and min | |
| 2024-02-06 | — | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and mi | |
| 2024-02-06 | — | Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and min | |
| 2024-01-02 | — | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC c | |
| 2024-01-02 | — | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line | |
| 2024-01-02 | — | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC c | |
| 2024-01-02 | — | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC compo | |
| 2024-01-02 | — | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC compo | |
| 2023-12-12 | — | Philips Azurion system, Interventional fluoroscopic x-ray system.
System Product Name - Model Num | |
| 2023-12-08 | — | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.0 | |
| 2023-12-08 | — | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.0 | |
| 2023-11-03 | — | Philips Azurion systems with monoplane fixed ceiling mounts:
722078 Azurion 7 M12
722079 Azurion 7 M | |
| 2023-11-03 | — | Philips Allura systems with monoplane fixed ceiling mounts:
722001 Allura Xper FD10C
722003 Allura | |
| 2023-08-15 | — | Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva syste | |
| 2023-06-30 | — | Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X- | |
| 2023-06-12 | — | Azurion 7 M20. X-ray Image guided Therapy System. | |
| 2023-06-12 | — | Allura Xper FD10 and FD20. X-ray Imaging System. | |
| 2023-03-21 | — | Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.
Models/Mo | |
| 2023-02-20 | — | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 | |
| 2023-02-20 | — | 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 | |
| 2021-12-02 | — | Zenition 70, Model #718133 | |
| 2021-12-02 | — | Zenition 50, Model #718096 | |
| 2021-12-02 | — | Veradius Unity, Model #718132 | |
| 2021-05-26 | — | Azurion systems with software release R1.x | |