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FDA 510(k)

MAGNETOM Amira

K-Number: K173600 · 2017-12-19

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-12-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Amira 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 2017-12-19 under 510(k) number K173600. 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 Amira is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K173600.

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

MAGNETOM Amira received FDA 510(k) clearance on 2017-12-19, under 510(k) number K173600.

Who is the listed applicant for MAGNETOM Amira?

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 Amira?

The FDA product code for MAGNETOM Amira 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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