FDA product code EGT: Controller, Temperature, Radiographic
EGT is the FDA product code for controller, temperature, radiographic. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel. Devices under EGT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Controller, Temperature, Radiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for EGT devices
openFDA lists no recalls for product code EGT.
Frequently asked questions
What is FDA product code EGT?
EGT is the FDA product code for controller, temperature, radiographic. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel.
What device class is EGT?
Class II, regulation 21 CFR 892.1900. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EGT
- Run a recall and safety report across every EGT manufacturer
- Watch product code EGT 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.