21 CFR 892.1960 — Screen, Intensifying, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1960
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EAM | Screen, Intensifying, Radiographic | 1 | 35 | |
| QHX | Fluoroscopic X-Ray Image Intensifier | 1 | 0 |
