510(k) K881305

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM by Toshiba Medical Systems — Product Code JAK

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