510(k) K960948

SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A by Toshiba Medical Systems — Product Code KPS

K960948 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems for the device "SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Toshiba Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
March 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type