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FDA 510(k)

MAGNETOM Free.Max; MAGNETOM Free.Star

K-Number: K251822 · 2025-11-20

ApplicantSiemens Shenzhen Magnetic Resonance , Ltd.
Decision Date2025-11-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Free.Max; MAGNETOM Free.Star is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Shenzhen Magnetic Resonance , Ltd.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K251822. 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 MAGNETOM Free.Max; MAGNETOM Free.Star?

MAGNETOM Free.Max; MAGNETOM Free.Star is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Siemens Shenzhen Magnetic Resonance , Ltd.. The 510(k) number is K251822.

When did MAGNETOM Free.Max; MAGNETOM Free.Star receive FDA 510(k) clearance?

MAGNETOM Free.Max; MAGNETOM Free.Star received FDA 510(k) clearance on 2025-11-20, under 510(k) number K251822.

Who is the listed applicant for MAGNETOM Free.Max; MAGNETOM Free.Star?

The FDA 510(k) record lists Siemens Shenzhen Magnetic Resonance , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNETOM Free.Max; MAGNETOM Free.Star?

The FDA product code for MAGNETOM Free.Max; MAGNETOM Free.Star is LNH.

Other records listing Siemens Shenzhen Magnetic Resonance , Ltd. 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.

K260265MAGNETOM Flow.Ace; MAGNETOM Flow.PlusK250436MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

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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