21 CFR 892.2050
Medical image management and processing system
21 CFR 892.2050 is the regulation titled “Medical image management and processing system” in 21 CFR Part 892, Radiology Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 803.12, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 892.2050 most often, as written in the letters.
- 1 letterFailure to submit any report required within 10 working days of initiating a correction or removal, as required by 21 CFR 806.10
The regulation
Read the text of 21 CFR 892.2050 (eCFR, as of Sep 1, 2026)
(a) Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
[63 FR 23387, Apr. 29, 1998, as amended at 86 FR 20284, Apr. 19, 2021]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 892.2050.
- 21 CFR 803.12How do I submit initial and supplemental or followup reports?1 letter cites both
- 21 CFR 803.3How does FDA define the terms used in this part?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.160Distribution1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
Latest letters citing it
The letter citing 21 CFR 892.2050 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.