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FDA 510(k)

ECHELON OVAL V6.0A MRI System

K-Number: K172110 · 2018-01-11

ApplicantHitachi Healthcare Americas Corporation
Decision Date2018-01-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHELON OVAL V6.0A MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K172110. 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 V6.0A MRI System?

ECHELON OVAL V6.0A MRI System is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K172110.

When did ECHELON OVAL V6.0A MRI System receive FDA 510(k) clearance?

ECHELON OVAL V6.0A MRI System received FDA 510(k) clearance on 2018-01-11, under 510(k) number K172110.

Who is the listed applicant for ECHELON OVAL V6.0A MRI System?

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

What is the FDA product code for ECHELON OVAL V6.0A MRI System?

The FDA product code for ECHELON OVAL V6.0A MRI System is LNH.

Other records listing Hitachi Healthcare Americas 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.

K211406OASIS MRI SystemK202422Arietta 65K202030OASIS MRI SystemK200498SCENARIA ViewK192851OASIS MRI SystemK190841SCENARIA View

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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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