510(k) K850543
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 1985
- Date Received
- February 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5750
- Review Panel
- RA
- Submission Type