FDA product code LMD: System, Digital Image Communications, Radiological
LMD is the FDA product code for system, digital image communications, radiological. It is a Class I device, regulated under 21 CFR 892.2020 and reviewed by the Radiology panel. FDA has cleared 142 510(k) submissions under LMD, from 102 different applicants. The average 510(k) review took 123 days (median 90). FDA has posted 12 recalls for LMD devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Digital Image Communications, Radiological |
| Device class | Class I |
| Regulation | 21 CFR 892.2020 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LMD clearance
Top LMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 7 | 1998-06-18 |
| Dejarnette Research Systems | 7 | 1998-01-29 |
| Vortech Data, Inc. | 5 | 1993-01-15 |
| Merlin Engineering Works, Inc. | 4 | 1998-05-22 |
| Image Data Corp. | 4 | 1993-11-22 |
97 more applicants have LMD clearances. See the full list in Caduvo.
Most recent LMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K994329 | Terarecon,Inc. | IIVS INTEGRATED IMAGE VIEWING STATION | 2000-05-26 | 156 |
| K992698 | Stentor, Inc. | STENTOR, PAGEVIEW | 1999-10-25 | 75 |
| K992426 | Samsung Sds Co., Ltd. | RAYPAX WEB CLINICAL SYSTEM | 1999-10-13 | 84 |
| K992352 | Inteleradiology, Inc. | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 | 1999-09-29 | 77 |
| K991537 | Samsung Sds Co., Ltd. | SAMSUNG RAYPAX SYSTEM | 1999-07-06 | 64 |
Recalls for LMD devices
12 product recalls in 12 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-09-11.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code LMD?
LMD is the FDA product code for system, digital image communications, radiological. It is a Class I device, regulated under 21 CFR 892.2020 and reviewed by the Radiology panel.
What device class is LMD?
Class I, regulation 21 CFR 892.2020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LMD?
Across 142 cleared submissions the average was 123 days from receipt to decision (median 90).
Which companies have the most LMD clearances?
Eastman Kodak Company (7); Dejarnette Research Systems (7); Vortech Data, Inc. (5); Merlin Engineering Works, Inc. (4); Image Data Corp. (4).
Have LMD devices been recalled?
Yes: 12 product recalls across 12 recall events; the most recent began 2020-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LMD
- Run a recall and safety report across every LMD manufacturer
- Watch product code LMD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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