510(k) K943383
K943383 is an FDA 510(k) premarket notification submitted by Brit Systems, Inc. for the device "IMAGING WORKBENCH". The FDA issued a decision of Substantially Equivalent on Nov 22, 1994. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Brit Systems, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 22, 1994
- Date Received
- Jul 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Digital Image Communications, Radiological
- Device Class
- Class I
- Regulation Number
- 892.2020
- Review Panel
- RA
- Submission Type
- 510(k) Exempt
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.