DeviceClearance

Product code LMD— Radiology

STATVIEW

Classification name
System, Digital Image Communications, Radiological
Device class
Class 1
Regulation
21 CFR 892.2020
Advisory panel
Radiology
Total cleared
142
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code LMD under 21 CFR 892.2020, via openFDA

Market context for product code LMD

FDA has cleared 142 devices under product code LMD between 1985 and 2000, filed by 102 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code LMD

Recent clearances under product code LMD

1–100 of 142

Data sourced from openFDA. This site is unofficial and independent of the FDA.