JAA
- Product code
- JAA
- Device name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1650
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 300 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253103 | 2026-05-29 | Varex Imaging Corporation | Nexus DRF Digital X-ray Imaging System | |
| K251650 | 2025-09-16 | Imaging Engineering, LLC | Insight Enhanced DRF (EN-1002-01) | |
| K242488 | 2025-01-06 | Omega Medical Imaging, LLC | Soteria E-View | |
| K242948 | 2024-12-23 | Nrt X-Ray A/S | Adora DRFi (04550010) | FDA |
| K233380 | 2024-06-26 | Dornier Medtech America | TRIDENT Mobile Fluoroscopy System | FDA |
| K233945 | 2024-01-11 | Philips Medical Systems Dmc GmbH | ProxiDiagnost N90 / Precision CRF (706110, 706400) | FDA |
| K232910 | 2023-10-19 | Philips Medical Systems Dmc GmbH | CombiDiagnost R90 | |
| K232526 | 2023-09-12 | Canon Medical Systems Corporation | XIDF-AWS801, Angio Workstation (Alphenix Workstation |
Official FDA classification page: JAA
Classification and pathway per current FDA publications. Data from openFDA (CC0).