Product code JAA: 510(k) clearances and predicates
Product code JAA covers Nexus DRF Digital X-ray Imaging System. FDA lists 300 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
300 clearances on file under product code JAA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 so far | 1 |
Recent clearances
Newest JAA clearances in the FDA index, with applicant and decision date:
- K253103, Nexus DRF Digital X-ray Imaging System, applicant Varex Imaging Corporation, decided 2026-05-29. FDA record
- K251650, Insight Enhanced™ DRF (EN-1002-01), applicant Imaging Engineering, LLC, decided 2025-09-16. FDA record
- K242488, Soteria E-View, applicant Omega Medical Imaging, LLC, decided 2025-01-06. FDA record
- K242948, Adora DRFi (04550010), applicant Nrt X-Ray A/S, decided 2024-12-23. FDA record
- K233380, TRIDENT Mobile Fluoroscopy System, applicant Dornier Medtech America, decided 2024-06-26. FDA record
- K233945, ProxiDiagnost N90 / Precision CRF (706110, 706400), applicant Philips Medical Systems Dmc GmbH, decided 2024-01-11. FDA record
- K232910, CombiDiagnost R90, applicant Philips Medical Systems Dmc GmbH, decided 2023-10-19. FDA record
- K232526, XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5, applicant Canon Medical Systems Corporation, decided 2023-09-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Insight Enhanced™ DRF (EN-1002-01), Soteria E-View. Watch new JAA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JAA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JAA clearances include Nexus DRF Digital X-ray Imaging System.
How many 510(k) clearances use product code JAA?
300 at the time this page was generated, from openFDA records.
How do I find a predicate device under JAA?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JAA clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.