FDA product code IZC: Camera, Positron
IZC is the FDA product code for camera, positron. It is a Class I device, regulated under 21 CFR 892.1110 and reviewed by the Radiology panel. Devices under IZC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Positron |
| Device class | Class I |
| Regulation | 21 CFR 892.1110 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for IZC devices
openFDA lists no recalls for product code IZC.
Frequently asked questions
What is FDA product code IZC?
IZC is the FDA product code for camera, positron. It is a Class I device, regulated under 21 CFR 892.1110 and reviewed by the Radiology panel.
What device class is IZC?
Class I, regulation 21 CFR 892.1110. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code IZC
- Run a recall and safety report across every IZC manufacturer
- Watch product code IZC 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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