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FDA 510(k)

Promaxo MRI System II

K-Number: K232361 · 2023-09-05

ApplicantPromaxo, Inc.
Decision Date2023-09-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Promaxo MRI System II is the device name listed in this FDA 510(k) record. The listed applicant is Promaxo, Inc.. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K232361. 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 Promaxo MRI System II?

Promaxo MRI System II is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Promaxo, Inc.. The 510(k) number is K232361.

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

Promaxo MRI System II received FDA 510(k) clearance on 2023-09-05, under 510(k) number K232361.

Who is the listed applicant for Promaxo MRI System II?

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

What is the FDA product code for Promaxo MRI System II?

The FDA product code for Promaxo MRI System II is LNH.

Other records listing Promaxo, 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.

K202518Promaxo MRI 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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