510(k) K043146
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2005
- Date Received
- November 15, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type