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FDA 510(k)

neuro42 MRI System

K-Number: K232644 · 2024-02-08

ApplicantNeuro42, Inc.
Decision Date2024-02-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

neuro42 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Neuro42, Inc.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K232644. 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 neuro42 MRI System?

neuro42 MRI System is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Neuro42, Inc.. The 510(k) number is K232644.

When did neuro42 MRI System receive FDA 510(k) clearance?

neuro42 MRI System received FDA 510(k) clearance on 2024-02-08, under 510(k) number K232644.

Who is the listed applicant for neuro42 MRI System?

The FDA 510(k) record lists Neuro42, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neuro42 MRI System?

The FDA product code for neuro42 MRI System is LNH.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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