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FDA 510(k)

MAGNETOM Aera

K-Number: K190138 · 2019-02-15

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-02-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Aera is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K190138. 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 Aera?

MAGNETOM Aera is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K190138.

When did MAGNETOM Aera receive FDA 510(k) clearance?

MAGNETOM Aera received FDA 510(k) clearance on 2019-02-15, under 510(k) number K190138.

Who is the listed applicant for MAGNETOM Aera?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNETOM Aera?

The FDA product code for MAGNETOM Aera 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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