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FDA 510(k)

Vantage Galan 3T, MRT-3020, V4.0

K-Number: K162183 · 2016-11-25

ApplicantToshibamedical Systems Corporation
Decision Date2016-11-25
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Galan 3T, MRT-3020, V4.0 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 2016-11-25 under 510(k) number K162183. 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 Galan 3T, MRT-3020, V4.0?

Vantage Galan 3T, MRT-3020, V4.0 is a medical device that received FDA 510(k) clearance on 2016-11-25. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K162183.

When did Vantage Galan 3T, MRT-3020, V4.0 receive FDA 510(k) clearance?

Vantage Galan 3T, MRT-3020, V4.0 received FDA 510(k) clearance on 2016-11-25, under 510(k) number K162183.

Who is the listed applicant for Vantage Galan 3T, MRT-3020, V4.0?

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 Galan 3T, MRT-3020, V4.0?

The FDA product code for Vantage Galan 3T, MRT-3020, V4.0 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.

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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.

K261331I-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.K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation

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.

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