Cleared Traditional

K113093 - VANTAGE TITAN 3T

K113093 is the FDA 510(k) clearance for VANTAGE TITAN 3T by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K113093 · Toshibamedical Systems Corporation · Radiology device
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Jan 2012
Decision
86d
Days
Class 2
Risk

K113093 is an FDA 510(k) clearance for the VANTAGE TITAN 3T. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 86 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 Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K113093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date January 13, 2012
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K113093.
VANTAGE TITAN 3T
K120487 · Toshibamedical Systems Corporation · May 2012
ECHELON OVAL MRI SYSTEM
K113145 · Hitachi Medical Systems America, Inc. · May 2012
SPEEDUP SOFTWARE OPTION
K120748 · Esaote, S.P.A. · May 2012
OPTIMA MR450W
K113490 · Ge Medical Systems, LLC · Jan 2012
VANTAGE TITAN HSR
K112003 · Toshibamedical Systems Corporation · Dec 2011
MAGNETOM AERA AND MAGNETOM SKYRA
K111242 · Siemens Medical Solutions USA, Inc. · Nov 2011