FDA product code QHY: Solid State Fluoroscopic X-Ray Imager
QHY is the FDA product code for solid state fluoroscopic x-ray imager. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel. Devices under QHY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density.
Classification
| Field | Value |
|---|---|
| Device name | Solid State Fluoroscopic X-Ray Imager |
| Device class | Class II |
| Regulation | 21 CFR 892.1650 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for QHY devices
openFDA lists no recalls for product code QHY.
Frequently asked questions
What is FDA product code QHY?
QHY is the FDA product code for solid state fluoroscopic x-ray imager. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel.
What device class is QHY?
Class II, regulation 21 CFR 892.1650. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QHY
- Run a recall and safety report across every QHY manufacturer
- Watch product code QHY 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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