510(k) K042133
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2004
- Date Received
- August 9, 2004
- 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