510(k) K082269
K082269 is an FDA 510(k) premarket notification submitted by Visage Imaging, Inc. for the device "VISAGE PACS, VERSION 6.0/CS 3.1". The FDA issued a decision of Substantially Equivalent on Dec 12, 2008. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Visage Imaging, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2008
- Date Received
- Aug 11, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)