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System, Digital Image Communications, Radiological

FDA product code LMD · 142 cleared devices

Class 1 Radiology
Regulation
21 CFR 892.2020
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1985-10-16 – 2000-05-26

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.

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