Cleared Traditional

K032490 - TOSHIBA EXCELART VANTAGE XGV/AGV MRI DI...

K032490 is the FDA 510(k) clearance for TOSHIBA EXCELART VANTAGE XGV/AGV MRI DI... by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K032490 · Toshiba America Medical Systems, In.C · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
9d
Days
Class 2
Risk

K032490 is an FDA 510(k) clearance for the TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AN.... Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on August 21, 2003 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 K032490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2003
Decision Date August 21, 2003
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.
LAURA DANIELSON

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.

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ECLIPSE
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