System, Digital Image Communications, Radiological
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 yearShow the numbers
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 3 |
| 1990 | 3 |
| 1991 | 3 |
| 1992 | 9 |
| 1993 | 22 |
| 1994 | 14 |
| 1995 | 21 |
| 1996 | 20 |
| 1997 | 20 |
| 1998 | 14 |
| 1999 | 5 |
| 2000 | 1 |
Applicants with the most clearances
Product code LMD| Applicant | Clearances |
|---|---|
| Dejarnette Research Systems | 7 |
| Eastman Kodak Company | 7 |
| Philips North America LLC | 5 |
| Vortech Data, Inc. | 5 |
| Image Data Corp. | 4 |
| Merlin Engineering Works, Inc. | 4 |
| Advanced Video Products, Inc. | 3 |
| Evergreen Technologies, Inc. | 3 |
| Olicon Imaging Systems, Inc. | 3 |
| Siemens Gammasonics, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
