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FDA 510(k)

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

K-Number: K250436 · 2025-06-16

Decision Date2025-06-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus is a medical device manufactured by Siemens Shenzhen Magnetic Resonance , Ltd.. It received FDA 510(k) clearance on 2025-06-16 under approval number K250436. 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 2025-06-16. It is manufactured by Siemens Shenzhen Magnetic Resonance , Ltd.. The 510(k) number is K250436.

When was MAGNETOM Flow.Ace; MAGNETOM Flow.Plus approved by the FDA?

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus received FDA 510(k) clearance on 2025-06-16, under approval number K250436.

What company makes MAGNETOM Flow.Ace; MAGNETOM Flow.Plus?

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus is manufactured by Siemens Shenzhen Magnetic Resonance , Ltd..

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 Devices by Siemens Shenzhen Magnetic Resonance , Ltd.

Related Devices (Code: LNH)

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.