---
kind: "section"
citation: "21 C.F.R. § 892.2010"
title: "21"
number: "892.2010"
heading: "Medical image storage device."
url: "https://uscodex.org/cfr/21/892.2010"
---

# §892.2010. 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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 892.9](/cfr/21/892.9.md).

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

### Amendments

[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]