Cleared Traditional

K960948 - SCATTER CORRECTION VOLUME SOFTWARE MODE...

K960948 is an FDA 510(k) clearance for SCATTER CORRECTION VOLUME SOFTWARE MODE..., manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K960948 · Toshiba Medical Systems · Radiology device
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
290d
Days
Class 2
Risk

K960948 is an FDA 510(k) clearance for the SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 290 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba Medical Systems devices

FDA 510(k) Submission Details - K960948

510(k) Number K960948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1996
Decision Date December 23, 1996
Days to Decision 290 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 107d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K960948.
PRISM XPVT SYSTEM (210823)
K964712 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · Elscint, Inc. · Jan 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · GE Medical Systems · Jan 1997
QUANTEM
K963162 · Elscint, Inc. · Nov 1996
MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
K962738 · GE Medical Systems · Oct 1996
STEP OPTION TO PRISM 2000
K960865 · Philips Medical Systems (Cleveland), Inc. · Sep 1996