(a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

(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 §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]


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