QHX · Fluoroscopic X-Ray Image Intensifier
Radiology · 21 CFR 892.1960 · Class 1
Overview
| Product Code | QHX |
|---|---|
| Device Name | Fluoroscopic X-Ray Image Intensifier |
| Regulation | 21 CFR 892.1960 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
