Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vantage Titan 1.5T, MRT-1510, M-Power GX

K-Number: K170412 · 2017-06-07

ApplicantToshibamedical Systems Corporation
Decision Date2017-06-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Titan 1.5T, MRT-1510, M-Power GX is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K170412. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vantage Titan 1.5T, MRT-1510, M-Power GX?

Vantage Titan 1.5T, MRT-1510, M-Power GX is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170412.

When did Vantage Titan 1.5T, MRT-1510, M-Power GX receive FDA 510(k) clearance?

Vantage Titan 1.5T, MRT-1510, M-Power GX received FDA 510(k) clearance on 2017-06-07, under 510(k) number K170412.

Who is the listed applicant for Vantage Titan 1.5T, MRT-1510, M-Power GX?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vantage Titan 1.5T, MRT-1510, M-Power GX?

The FDA product code for Vantage Titan 1.5T, MRT-1510, M-Power GX is LNH.

Other records listing Toshibamedical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemK173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0K173088Vitrea Software Toshiba Package VSTP-001AK173382Vantage Galan 3T, V4.6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4K172863Infinix-i, INFX-8000V, V7.0

View all 27 devices →

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑