510(k) K071297
K071297 is an FDA 510(k) premarket notification submitted by Agfa Healthcare Corp. for the device "IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)". The FDA issued a decision of Substantially Equivalent on Jun 22, 2007. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Agfa Healthcare Corp. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2007
- Date Received
- May 9, 2007
- 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)