FDA product code QHX: Fluoroscopic X-Ray Image Intensifier
QHX is the FDA product code for fluoroscopic x-ray image intensifier. It is a Class I device, regulated under 21 CFR 892.1960 and reviewed by the Radiology panel. Devices under QHX reach the market by 510(k) exempt; 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 | Fluoroscopic X-Ray Image Intensifier |
| Device class | Class I |
| Regulation | 21 CFR 892.1960 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for QHX devices
openFDA lists no recalls for product code QHX.
Frequently asked questions
What is FDA product code QHX?
QHX is the FDA product code for fluoroscopic x-ray image intensifier. It is a Class I device, regulated under 21 CFR 892.1960 and reviewed by the Radiology panel.
What device class is QHX?
Class I, regulation 21 CFR 892.1960. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QHX
- Run a recall and safety report across every QHX manufacturer
- Watch product code QHX 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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