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FDA 510(k)

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software

K-Number: K163312 · 2017-01-27

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-01-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software 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 2017-01-27 under 510(k) number K163312. 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 and MAGNETOM Skyra with syngo MR E11C - AP02 Software?

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K163312.

When did MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software receive FDA 510(k) clearance?

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163312.

Who is the listed applicant for MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software?

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 and MAGNETOM Skyra with syngo MR E11C - AP02 Software?

The FDA product code for MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software is LNH.

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Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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