510(k) K232799
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2024
- Date Received
- September 12, 2023
- 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