510(k) K884555
K884555 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems for the device "TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM". The FDA issued a decision of Substantially Equivalent on February 27, 1989. 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
- February 27, 1989
- Date Received
- October 31, 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