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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(a) Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.
(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.
[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000; 86 FR 20284, Apr. 19, 2021]