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FDA 510(k)

MAGNETOM Amira; MAGNETOM Sempra

K-Number: K223343 · 2023-03-28

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-03-28
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Amira; MAGNETOM Sempra is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-03-28 under approval number K223343. 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 Amira; MAGNETOM Sempra?

MAGNETOM Amira; MAGNETOM Sempra is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K223343.

When was MAGNETOM Amira; MAGNETOM Sempra approved by the FDA?

MAGNETOM Amira; MAGNETOM Sempra received FDA 510(k) clearance on 2023-03-28, under approval number K223343.

What company makes MAGNETOM Amira; MAGNETOM Sempra?

MAGNETOM Amira; MAGNETOM Sempra is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for MAGNETOM Amira; MAGNETOM Sempra?

The FDA product code for MAGNETOM Amira; MAGNETOM Sempra is LNH.

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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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