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FDA 510(k)

ECHELON Oval V 5.1 MRI System

K-Number: K153547 · 2016-03-31

ApplicantHitachi Medical Systems America, Inc.
Decision Date2016-03-31
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHELON Oval V 5.1 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K153547. 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 ECHELON Oval V 5.1 MRI System?

ECHELON Oval V 5.1 MRI System is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K153547.

When did ECHELON Oval V 5.1 MRI System receive FDA 510(k) clearance?

ECHELON Oval V 5.1 MRI System received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153547.

Who is the listed applicant for ECHELON Oval V 5.1 MRI System?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHELON Oval V 5.1 MRI System?

The FDA product code for ECHELON Oval V 5.1 MRI System is LNH.

Other records listing Hitachi Medical Systems America, Inc. 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.

K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K161748SUPRIA w/guideShot OptionK160152Trillium Oval V 5.1 MRI System

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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