510(k) K001700
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2000
- Date Received
- June 5, 2000
- Clearance Type
- Special
- 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