FDA product code JAE: Microtron, Medical
JAE is the FDA product code for microtron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. Devices under JAE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microtron, Medical |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for JAE devices
openFDA lists no recalls for product code JAE.
Frequently asked questions
What is FDA product code JAE?
JAE is the FDA product code for microtron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is JAE?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JAE
- Run a recall and safety report across every JAE manufacturer
- Watch product code JAE 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.
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