FDA product code JAR: Phantom, Test-Pattern, Radionuclide
JAR is the FDA product code for phantom, test-pattern, radionuclide. It is a Class I device, regulated under 21 CFR 892.1420 and reviewed by the Radiology panel. Devices under JAR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Phantom, Test-Pattern, Radionuclide |
| Device class | Class I |
| Regulation | 21 CFR 892.1420 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for JAR devices
openFDA lists no recalls for product code JAR.
Frequently asked questions
What is FDA product code JAR?
JAR is the FDA product code for phantom, test-pattern, radionuclide. It is a Class I device, regulated under 21 CFR 892.1420 and reviewed by the Radiology panel.
What device class is JAR?
Class I, regulation 21 CFR 892.1420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JAR
- Run a recall and safety report across every JAR manufacturer
- Watch product code JAR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.