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FDA 510(k)

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

K-Number: K260265 · 2026-02-23

ApplicantSiemens Shenzhen Magnetic Resonance , Ltd.
Decision Date2026-02-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus 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 2026-02-23 under 510(k) number K260265. 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 Flow.Ace; MAGNETOM Flow.Plus?

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Siemens Shenzhen Magnetic Resonance , Ltd.. The 510(k) number is K260265.

When did MAGNETOM Flow.Ace; MAGNETOM Flow.Plus receive FDA 510(k) clearance?

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus received FDA 510(k) clearance on 2026-02-23, under 510(k) number K260265.

Who is the listed applicant for MAGNETOM Flow.Ace; MAGNETOM Flow.Plus?

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 Flow.Ace; MAGNETOM Flow.Plus?

The FDA product code for MAGNETOM Flow.Ace; MAGNETOM Flow.Plus 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.

K251822MAGNETOM Free.Max; MAGNETOM Free.StarK250436MAGNETOM 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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