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FDA 510(k)

MRIaudio PREM System with MRIview

K-Number: K193102 · 2020-01-06

ApplicantMriaudio, Inc.
Decision Date2020-01-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRIaudio PREM System with MRIview is the device name listed in this FDA 510(k) record. The listed applicant is Mriaudio, Inc.. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K193102. 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 MRIaudio PREM System with MRIview?

MRIaudio PREM System with MRIview is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Mriaudio, Inc.. The 510(k) number is K193102.

When did MRIaudio PREM System with MRIview receive FDA 510(k) clearance?

MRIaudio PREM System with MRIview received FDA 510(k) clearance on 2020-01-06, under 510(k) number K193102.

Who is the listed applicant for MRIaudio PREM System with MRIview?

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

What is the FDA product code for MRIaudio PREM System with MRIview?

The FDA product code for MRIaudio PREM System with MRIview is LNH.

Other records listing Mriaudio, 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.

K180100MRIaudio PREM 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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