Cleared Traditional

K032915 - ADVANTAGE 4D OPTION

K032915 is the FDA 510(k) clearance for ADVANTAGE 4D OPTION by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K032915 · Ge Medical Systems, LLC · Radiology device
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Oct 2003
Decision
38d
Days
Class 2
Risk

K032915 is an FDA 510(k) clearance for the ADVANTAGE 4D OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 38 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 Ge Medical Systems, LLC devices

Submission Details

510(k) Number K032915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date October 30, 2003
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 Rheinland of North America, Inc.
JUERGEN WELTE

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 607
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K032915.
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · Siemens Medical Solutions USA, Inc. · Nov 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · Siemens Medical Solutions USA, Inc. · Nov 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418 · Toshiba America Medical Systems, In.C · Nov 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · Philips Medical Systems, Inc. · Oct 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469 · Toshiba America Medical Systems, In.C · May 2003
CT COLONOGRAPHY
K023943 · Ge Medical Systems, Inc. · May 2003