DIGIRAY
Device Facts
| Record ID | K926098 |
|---|---|
| Device Name | DIGIRAY |
| Applicant | Telescan Corp. |
| Product Code | LMD · Radiology |
| Decision Date | Jun 25, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2020 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. 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. This does not include electronic transfer of medical image software functions.
