510(k) K092280
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2009
- Date Received
- July 28, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type