510(k) K884788

TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM by Toshiba Medical Systems — Product Code JAK

K884788 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems for the device "TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM". 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
November 15, 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