21 CFR 892.1640 — System, X-Ray, Film Marking, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1640
Identification
A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.
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 |
|---|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | 1 | 18 |
