(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]