LMD

System, Digital Image Communications, Radiological

Product code

LMD

Device name

System, Digital Image Communications, Radiological

Device class

Class 1

21 CFR

21 CFR 892.2020

Medical specialty

Radiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

142 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).