System, Digital Image Communications, Radiological
LMD · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.2020
Classification
FDA Product Code
LMD
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 892.2020
Review panel
RA
Medical specialty
Radiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.