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FDA 510(k)

MAGNETOM Sempra with syngo MR E11S

K-Number: K163211 · 2017-01-27

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

Device Summary

MAGNETOM Sempra with syngo MR E11S 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 K163211. 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 Sempra with syngo MR E11S?

MAGNETOM Sempra with syngo MR E11S 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 K163211.

When did MAGNETOM Sempra with syngo MR E11S receive FDA 510(k) clearance?

MAGNETOM Sempra with syngo MR E11S received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163211.

Who is the listed applicant for MAGNETOM Sempra with syngo MR E11S?

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 Sempra with syngo MR E11S?

The FDA product code for MAGNETOM Sempra with syngo MR E11S 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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, 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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