510(k) K994329
K994329 is an FDA 510(k) premarket notification submitted by Terarecon,Inc. for the device "IIVS INTEGRATED IMAGE VIEWING STATION". The FDA issued a decision of Substantially Equivalent on May 26, 2000. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Terarecon,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2000
- Date Received
- December 22, 1999
- 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
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.