21 CFR § 892.2030 - Medical image digitizer.

---
identifier: "/us/cfr/t21/s892.2030"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.2030 - Medical image digitizer."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.2030"
section_name: "Medical image digitizer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 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 of this chapter subject to the limitations in § 892.9.

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