Cleared Traditional

K120638 - VANTAGE TITAN

K120638 is an FDA 510(k) clearance for VANTAGE TITAN, 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 92-day FDA review.

K120638 · Toshibamedical Systems Corporation · Radiology device
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Jun 2012
Decision
92d
Days
Class 2
Risk

K120638 is an FDA 510(k) clearance for the VANTAGE TITAN. 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 June 1, 2012 after a review of 92 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 - K120638

510(k) Number K120638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date June 01, 2012
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
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 K120638.
MAGNETOM SPECTRA
K121160 · Siemens Medical Solutions USA, Inc. · Jul 2012
S-SCAN
K121650 · Esaote, S.P.A. · Jul 2012
BELLYBOARD, SBRT ACCESSORIES
K121545 · Medtec Inc. Dba Civco Medical Solutions · Jun 2012
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
K121239 · Optoacoustics, Ltd. · May 2012
VANTAGE TITAN 3T
K120487 · Toshibamedical Systems Corporation · May 2012
MRI SYTEMS
K113281 · Shenzhen Anke High-Tech Co., Ltd. · May 2012