510(k) K984000
K984000 is an FDA 510(k) premarket notification submitted by Surgical Navigation Technologies, Inc. for the device "STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 1999. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Surgical Navigation Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1999
- Date Received
- November 10, 1998
- 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.