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Code · CFR · Title 21 — Food and Drugs · Part 892 — Radiology Devices · § 892.2010

§ 892.2010. Medical image storage device.

91 words·~1 min read·/us/cfr/t21/s§ 892.2010·

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(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]
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§ 892.2010
Medical image storage device.
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