Cleared Traditional

K122613 - VANTAGE TITAN WITH HELIOS GRADIENT MODE...

K122613 is the FDA 510(k) clearance for VANTAGE TITAN WITH HELIOS GRADIENT MODE... 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 108-day FDA review.

K122613 · Toshiba America Medical Systems, In.C · Radiology device
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Dec 2012
Decision
108d
Days
Class 2
Risk

K122613 is an FDA 510(k) clearance for the VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US. 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 December 13, 2012 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K122613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2012
Decision Date December 13, 2012
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
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
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