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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Subscribe to: 21 CFR 892.1960
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
(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.
[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]