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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 a medical device manufactured by Siemens Shenzhen Magnetic Resonance , Ltd.. It received FDA 510(k) clearance on 2025-11-20 under approval 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. It is manufactured by Siemens Shenzhen Magnetic Resonance , Ltd.. The 510(k) number is K251822.

When was MAGNETOM Free.Max; MAGNETOM Free.Star approved by the FDA?

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

What company makes MAGNETOM Free.Max; MAGNETOM Free.Star?

MAGNETOM Free.Max; MAGNETOM Free.Star is manufactured by Siemens Shenzhen Magnetic Resonance , Ltd..

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 Devices by Siemens Shenzhen Magnetic Resonance , Ltd.

K250436MAGNETOM Flow.Ace; MAGNETOM Flow.Plus K260265MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, 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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