System, Digital Image Communications, Radiological

What Is It?

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.

What Is FDA Product Code LMD?

System, Digital Image Communications, Radiological is FDA product code LMD, Class 1, 21 CFR 892.2020.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 12 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Software design (5), Nonconforming Material/Component (2) and Software Manufacturing/Software Deployment (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.