510(k) K881305
K881305 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems for the device "TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM". The FDA issued a decision of Substantially Equivalent on October 19, 1988. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Toshiba Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1988
- Date Received
- March 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type