Spot-film device.

21 C.F.R. § 892.1670
in effectEffective: 2024-07-01
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(a) Identification. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b) Classification. Class II (special 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.

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