FDA product code OQT: Prostate Lesion, Documentation, System
OQT is the FDA product code for prostate lesion, documentation, system. It is a Class II device, regulated under 21 CFR 876.2050 and reviewed by the Gastroenterology and Urology panel. Devices under OQT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
Classification
| Field | Value |
|---|---|
| Device name | Prostate Lesion, Documentation, System |
| Device class | Class II |
| Regulation | 21 CFR 876.2050 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for OQT devices
openFDA lists no recalls for product code OQT.
Frequently asked questions
What is FDA product code OQT?
OQT is the FDA product code for prostate lesion, documentation, system. It is a Class II device, regulated under 21 CFR 876.2050 and reviewed by the Gastroenterology and Urology panel.
What device class is OQT?
Class II, regulation 21 CFR 876.2050. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OQT
- Run a recall and safety report across every OQT manufacturer
- Watch product code OQT 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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