510(k) K851687
K851687 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems for the device "JUMBO DIGITAL GAMMACAMERA GCA-90B". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310. Toshiba Medical Systems has at least 10 other 510(k) clearances on record.
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