Cleared Traditional

K031469 - AQUILION SUPER 4 MULTISLICE CT SCANNER

K031469 is the FDA 510(k) clearance for AQUILION SUPER 4 MULTISLICE CT SCANNER 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 13-day FDA review.

K031469 · Toshiba America Medical Systems, In.C · Radiology device
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May 2003
Decision
13d
Days
Class 2
Risk

K031469 is an FDA 510(k) clearance for the AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7. 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 May 22, 2003 after a review of 13 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 K031469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2003
Decision Date May 22, 2003
Days to Decision 13 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
94d faster than avg
Panel avg: 107d · This submission: 13d
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.

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 K031469.
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418 · Toshiba America Medical Systems, In.C · Nov 2003
ADVANTAGE 4D OPTION
K032915 · Ge Medical Systems, LLC · Oct 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · Philips Medical Systems, Inc. · Oct 2003
CT COLONOGRAPHY
K023943 · Ge Medical Systems, Inc. · May 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
K030450 · J. Morita USA, Inc. · May 2003
CARD EP
K031261 · GE Medical Systems · May 2003