Cleared Traditional

K172878 - Vantage Titan 3T

K172878 is the FDA 510(k) clearance for Vantage Titan 3T by Toshiba Medical Systems Corporation, Japan. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K172878 · Toshiba Medical Systems Corporation, Japan · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
57d
Days
Class 2
Risk

K172878 is an FDA 510(k) clearance for the Vantage Titan 3T, MRT-3010/A7, M-Power GX. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba Medical Systems Corporation, Japan (Otawara-Shi, JP). The FDA issued a Cleared decision on November 17, 2017 after a review of 57 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 Medical Systems Corporation, Japan devices

Submission Details

510(k) Number K172878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date November 17, 2017
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
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 818
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K172878.
3D APT
K172920 · Philips Medical Systems Nederland B.V. · Jan 2018
ECHELON OVAL V6.0A MRI System
K172110 · Hitachi Healthcare Americas Corporation · Jan 2018
MAGNETOM Amira
K173600 · Siemens Medical Solutions USA, Inc. · Dec 2017
MAGNETOM Terra
K170840 · Siemens Medical Solutions USA, Inc. · Oct 2017
Vantage Elan 1.5T, V4.0
K171597 · Toshibamedical Systems Corporation · Jul 2017
SIGNA Premier
K171128 · Ge Medical Systems, LLC · Jul 2017