JAA — System, X-Ray, Fluoroscopic, Image-Intensified Class II
FDA Device Classification
Classification Details
- Product Code
- JAA
- Device Class
- Class II
- Regulation Number
- 892.1650
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251650 | imaging engineering | Insight Enhanced DRF (EN-1002-01) | September 16, 2025 |
| K242488 | omega medical imaging | Soteria E-View | January 6, 2025 |
| K242948 | nrt x-ray | Adora DRFi (04550010) | December 23, 2024 |
| K233380 | dornier medtech america | TRIDENT Mobile Fluoroscopy System | June 26, 2024 |
| K233945 | philips medical systems dmc | ProxiDiagnost N90 / Precision CRF (706110, 706400) | January 11, 2024 |
| K232910 | philips medical systems dmc | CombiDiagnost R90 | October 19, 2023 |
| K232526 | canon medical systems corporation | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | September 12, 2023 |
| K220871 | dornier medtech america | Nautilus | April 18, 2022 |
| K212890 | omega medical imaging | Nyquist.IQ | December 13, 2021 |
| K212837 | philips medical systems dmc | ProxiDiagnost N90 | September 21, 2021 |
| K212145 | agfa n.v | DR 800 with DSA, DR 800 | August 31, 2021 |
| K210469 | imaging engineering | Insight Agile DRF | July 27, 2021 |
| K203428 | ziehm imaging | Ziehm Vision RFD | March 17, 2021 |
| K203010 | apelem-dms group | Platinum dRF Imaging System | January 22, 2021 |
| K200965 | karl storz endoscopy america | XR-MX/1000 | December 29, 2020 |
| K203087 | philips medical systems dmc | CombiDiagnost R90 | December 3, 2020 |
| K202235 | cmt medical technologies | ArtPIX DRF | September 3, 2020 |
| K200396 | imaging engineering | Insight Enhanced DRF Digital Imaging System | March 6, 2020 |
| K191713 | omega medical imaging | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroS | October 4, 2019 |
| K191504 | radiology information systems | PowerDR | August 16, 2019 |