Cleared Traditional

K120487 - VANTAGE TITAN 3T

K120487 is an FDA 510(k) clearance for VANTAGE TITAN 3T, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K120487 · Toshibamedical Systems Corporation · Radiology device
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May 2012
Decision
96d
Days
Class 2
Risk

K120487 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 May 23, 2012 after a review of 96 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 Toshibamedical Systems Corporation devices

FDA 510(k) Submission Details - K120487

510(k) Number K120487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date May 23, 2012
Days to Decision 96 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
11d faster than avg
Panel avg: 107d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 965
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K120487.
BELLYBOARD, SBRT ACCESSORIES
K121545 · Medtec Inc. Dba Civco Medical Solutions · Jun 2012
VANTAGE TITAN
K120638 · Toshibamedical Systems Corporation · Jun 2012
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K121239 · Optoacoustics, Ltd. · May 2012
MRI SYTEMS
K113281 · Shenzhen Anke High-Tech Co., Ltd. · May 2012
ECHOSTAR SPICA 1.5T MR SYSTEM
K113511 · Alltech Medical Systems America, Inc. · May 2012
ECHELON OVAL MRI SYSTEM
K113145 · Hitachi Medical Systems America, Inc. · May 2012