Title 21

SECTION 892.1640

892.1640 Radiographic film marking system.

§ 892.1640 Radiographic film marking system.

(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]

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