Product code JAA
- Device name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1650
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251650 | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025-09-16 |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | 2025-01-06 |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | 2024-12-23 |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | 2024-06-26 |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | 2024-01-11 |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2023-10-19 |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | 2023-09-12 |
| K220871 | Nautilus | Dornier Medtech America, Inc. | 2022-04-18 |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | 2021-12-13 |
| K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021-09-21 |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021-08-31 |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | 2021-07-27 |
| K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2021-03-17 |
| K203010 | Platinum dRF Imaging System | Apelem-Dms Group | 2021-01-22 |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | 2020-12-29 |
| K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2020-12-03 |
| K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | 2020-09-03 |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | 2020-03-06 |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) | Omega Medical Imaging, LLC | 2019-10-04 |
| K191504 | PowerDR | Radiology Information Systems, Inc. | 2019-08-16 |
| K191877 | FLUOROspeed | Shimadzu Corporation | 2019-08-05 |
| K191310 | Insight Essentials DRF Digital Imaging System | Imaging Engineering, LLC | 2019-06-10 |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019-03-29 |
| K190373 | SonialVision G4 | Shimadzu Corporation | 2019-03-15 |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | 2018-05-21 |
| K180651 | Uroview FD II | Pausch Medical GmbH | 2018-04-12 |
| K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | 2018-04-05 |
| K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017-01-31 |
| K161019 | Uroview FD | Pausch Medical GmbH | 2016-08-17 |
| K160301 | Platinum dRF Imaging System | Apelem-Dms Group | 2016-03-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809244060632 | Genoray | GENORAY CO., LTD. | 2026-04-10 |
| 08809244060533 | Genoray | GENORAY CO., LTD. | 2026-04-10 |
| 08809244060557 | Genoray | GENORAY CO., LTD. | 2026-04-10 |
| 08809244060625 | Genoray | GENORAY CO., LTD. | 2025-12-01 |
| 08809244060618 | Genoray | GENORAY CO., LTD. | 2025-12-01 |
| 08800018422601 | EXTRON 3 | DRTECH Corporation | 2025-06-17 |
| 08809244060090 | Genoray | GENORAY CO., LTD. | 2025-05-02 |
| 08800018420805 | EXTRON 5 | DRTECH Corporation | 2023-08-24 |
| 08800018420904 | EXTRON 7 | DRTECH Corporation | 2023-08-24 |
| 08809244060120 | Genoray | GENORAY CO., LTD. | 2022-03-22 |
| 08800018600900 | 0909FCB | Rayence Co., Ltd. | 2021-10-29 |
| EZIEZIEHMVISIONFD1651 | Ziehm Vision FD | Ziehm Imaging GmbH | 2020-03-12 |
| EZIEZIEHM80001 | Ziehm 8000 | Ziehm Imaging GmbH | 2020-03-12 |
| 08809244060113 | Genoray | GENORAY CO., LTD. | 2018-08-22 |
| 08809244060106 | Genoray | GENORAY CO., LTD. | 2018-08-22 |
| 08054890480055 | CLISIS SYSTEMS | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08054890480109 | Discovery RF180 | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08800019200253 | NA | ECOTRON | 2018-03-29 |
| 08800019200260 | NA | ECOTRON | 2018-03-29 |
| 08800019200277 | NA | ECOTRON | 2018-03-29 |
| EZIEZIEHMSOLOFD1 | Ziehm Solo FD | Ziehm Imaging GmbH | 2016-11-17 |
| 08800019200093 | NA | ECOTRON | 2016-11-05 |
| 08809244060083 | Genoray | GENORAY CO., LTD. | 2016-09-24 |
| 08809244060021 | Genoray | GENORAY CO., LTD. | 2016-09-24 |
| 08057737122019 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| EZIEZIEHMVISIONRFD3D1 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2016-09-23 |
| EZIEZIEHMVISIONRFD1 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2016-09-23 |
| EZIEZIEHMVISIONR1 | Ziehm Vision R | Ziehm Imaging GmbH | 2016-09-23 |
| EZIEZIEHMSOLO1 | Ziehm Solo | Ziehm Imaging GmbH | 2016-09-23 |
| 07630039100230 | MODULITH® | Storz Medical AG | 2016-08-24 |