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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 a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-01-27 under approval 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. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K163312.

When was MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software approved by the FDA?

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

What company makes MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software?

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software is manufactured by Siemens Medical Solutions USA, Inc..

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.

Other Devices by Siemens Medical Solutions USA, Inc.

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Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

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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