§ 892.1640. Radiographic film marking system.
82 words·~1 min read·
/us/cfr/t21/s§ 892.1640·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]