---
kind: "section"
citation: "21 C.F.R. § 892.2030"
title: "21"
number: "892.2030"
heading: "Medical image digitizer."
url: "https://uscodex.org/cfr/21/892.2030"
---

# §892.2030. Medical image digitizer.

- (a) **Identification.** A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
- (b) **Classification.** Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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 the limitations in [§ 892.9](/cfr/21/892.9.md).

## Notes

### Amendments

[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]

### 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, as amended at 84 FR 71819, Dec. 30, 2019]