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FDA 510(k)

fMRI Hardware System

K-Number: K191032 · 2019-11-27

ApplicantNordicneurolab AS
Decision Date2019-11-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

fMRI Hardware System is the device name listed in this FDA 510(k) record. The listed applicant is Nordicneurolab AS. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K191032. 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 fMRI Hardware System?

fMRI Hardware System is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Nordicneurolab AS. The 510(k) number is K191032.

When did fMRI Hardware System receive FDA 510(k) clearance?

fMRI Hardware System received FDA 510(k) clearance on 2019-11-27, under 510(k) number K191032.

Who is the listed applicant for fMRI Hardware System?

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

What is the FDA product code for fMRI Hardware System?

The FDA product code for fMRI Hardware System is LNH.

Other records listing Nordicneurolab AS 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.

K251937nordicAudio (1.0)K243209nordicMEDiVAK241608nordicMEDiVAK232680fMRI Hardware SystemK212720nordicDSCK163324nordicBrainEx

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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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