510(k) K072766
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2007
- Date Received
- September 28, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, X-Ray, Electrostatic
- Device Class
- Class II
- Regulation Number
- 892.1630
- Review Panel
- RA
- Submission Type