510(k) K062781
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2006
- Date Received
- September 18, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Beam-Shaping, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5710
- Review Panel
- RA
- Submission Type