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FDA 510(k)

Vantage Elan 1.5T, V4.0

K-Number: K171597 · 2017-07-21

ApplicantToshibamedical Systems Corporation
Decision Date2017-07-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Elan 1.5T, 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 2017-07-21 under 510(k) number K171597. 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 Elan 1.5T, V4.0?

Vantage Elan 1.5T, V4.0 is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K171597.

When did Vantage Elan 1.5T, V4.0 receive FDA 510(k) clearance?

Vantage Elan 1.5T, V4.0 received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171597.

Who is the listed applicant for Vantage Elan 1.5T, 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 Elan 1.5T, V4.0?

The FDA product code for Vantage Elan 1.5T, V4.0 is LNH.

Other records listing Toshibamedical Systems Corporation as applicant

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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.

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.

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