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Electronic Code of Federal Regulations

e-CFR data is current as of November 7, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.2010


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§892.2010   Medical image storage device.

(a) Identification. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, 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]

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