21 CFR 892.1850 — Cassette, Radiographic Film
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1850
Identification
A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IXA | Cassette, Radiographic Film | 2 | 51 |
Special Controls
IXA — Cassette, Radiographic Film
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
