FDA product code JAN: Counter, Whole Body, Nuclear
JAN is the FDA product code for counter, whole body, nuclear. It is a Class I device, regulated under 21 CFR 892.1130 and reviewed by the Radiology panel. Devices under JAN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Counter, Whole Body, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1130 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for JAN devices
openFDA lists no recalls for product code JAN.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0219 — Pet imaging whole body; melanoma for non-covered indications
Frequently asked questions
What is FDA product code JAN?
JAN is the FDA product code for counter, whole body, nuclear. It is a Class I device, regulated under 21 CFR 892.1130 and reviewed by the Radiology panel.
What device class is JAN?
Class I, regulation 21 CFR 892.1130. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JAN
- Run a recall and safety report across every JAN manufacturer
- Watch product code JAN 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.