21 C.F.R. § 892.1640 Radiographic film marking system.
Title 21 - Food and Drugs
(a) 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. (b) Classification. 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. [55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1640 Radiographic film marking system.
