21 CFR 892.1840 — Film, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1840
Identification
Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
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 the limitations in § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWZ | Film, Radiographic | 1 | 34 | |
| LQA | Media, Reusable Image | 1 | 1 |
