inforMED
LMDClass I

System, Digital Image Communications, Radiological

Radiology · 21 CFR 892.2020

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.

MDR events168All time
Recalls12All time
Registered firms151Currently listed
510(k) clearances142All time

Event type breakdown

Malfunction114
Injury25
Unspecified16
No answer provided6
Other6
Death1

Recalls

12 recall events for this product code

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