510(k) K090893
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2009
- Date Received
- March 31, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type