FDA product code OLQ: Cross-Sectional Mammographic Xray System
OLQ is the FDA product code for cross-sectional mammographic xray system. It is a Class III device, reviewed by the Radiology panel. Devices under OLQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Cross-Sectional Mammographic Xray System |
| Device class | Class III |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OLQ devices
openFDA lists no recalls for product code OLQ.
Frequently asked questions
What is FDA product code OLQ?
OLQ is the FDA product code for cross-sectional mammographic xray system. It is a Class III device, reviewed by the Radiology panel.
What device class is OLQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OLQ
- Run a recall and safety report across every OLQ manufacturer
- Watch product code OLQ 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times