JAA — System, X-Ray, Fluoroscopic, Image-Intensified Class II
FDA product code JAA covers "System, X-Ray, Fluoroscopic, Image-Intensified", a Class II medical device regulated under 21 CFR 892.1650. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253103 | varex imaging corporation | Nexus DRF Digital X-ray Imaging System | May 29, 2026 |
| 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 |