510(k) K033339
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2003
- Date Received
- October 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Simulation, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5840
- Review Panel
- RA
- Submission Type