Cleared Traditional

K023760 - CT CARDIAC FUNCTION ANALYSIS SOFTWARE

K023760 is the FDA 510(k) clearance for CT CARDIAC FUNCTION ANALYSIS SOFTWARE by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K023760 · Toshiba America Medical Systems, In.C · Radiology device
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Nov 2002
Decision
14d
Days
Class 2
Risk

K023760 is an FDA 510(k) clearance for the CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K023760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2002
Decision Date November 22, 2002
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 Consultant

Tuv America, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K023760.
CARD EP
K031261 · GE Medical Systems · May 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · GE Medical Systems · Mar 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · Philips Medical Systems (Cleveland), Inc. · Feb 2003
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · GE Medical Systems · Oct 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · GE Medical Systems · Sep 2002
LUNGCARE CT SOFTWARE PACKAGE
K022013 · Siemens Medical Solutions USA, Inc. · Jul 2002