510(k) K980220
K980220 is an FDA 510(k) premarket notification submitted by Sterling Diagnostic Imaging, Inc. for the device "IISYS PACS SYSTEM". The FDA issued a decision of Substantially Equivalent on February 13, 1998. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Sterling Diagnostic Imaging, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1998
- Date Received
- January 22, 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.