510(k) K093596
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2010
- Date Received
- November 20, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Beam Limiting, X-Ray, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type