Medical image storage device.

(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]