510(k) K021780
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2002
- Date Received
- May 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Simulation, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5840
- Review Panel
- RA
- Submission Type