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LMDClass I

System, Digital Image Communications, Radiological

21 CFR 892.2020 / Radiology

LMD is the FDA product code for System, Digital Image Communications, Radiological, a class I device type, regulated under 21 CFR 892.2020. FDA's definition for this code reads: "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...". As of , FDA records hold 142 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
LMD
Device name
System, Digital Image Communications, Radiological
FDA 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.
Regulation
21 CFR 892.2020
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
142
Ingested recalls
12

Clearances, product code LMD

By decision year
142 clearances under product code LMD with a decision year between 1985 and 2000, 1993 the highest year at 22.
Show the numbers
510(k) clearances under FDA product code LMD by decision year
YearClearances
19851
19863
19871
19882
19893
19903
19913
19929
199322
199414
199521
199620
199720
199814
19995
20001

Applicants with the most clearances

Product code LMD

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 143 companies shown, in name order