510(k) K851686
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1985
- Date Received
- April 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomographic, Nuclear
- Device Class
- Class II
- Regulation Number
- 892.1310
- Review Panel
- RA
- Submission Type