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FDA 510(k)

OASIS MRI System

K-Number: K202030 · 2020-10-21

ApplicantHitachi Healthcare Americas
Decision Date2020-10-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OASIS MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K202030. 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 OASIS MRI System?

OASIS MRI System is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K202030.

When did OASIS MRI System receive FDA 510(k) clearance?

OASIS MRI System received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202030.

Who is the listed applicant for OASIS MRI System?

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

What is the FDA product code for OASIS MRI System?

The FDA product code for OASIS MRI System is LNH.

Other records listing Hitachi Healthcare Americas 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 65K200498SCENARIA ViewK192851OASIS MRI SystemK190841SCENARIA ViewK191233ARIETTA 750

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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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