Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAGNETOM Avanto Fit

K-Number: K190757 · 2019-05-31

ApplicantSiemens Medical Solution USA, Inc.
Decision Date2019-05-31
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Avanto Fit is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190757. 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 Avanto Fit?

MAGNETOM Avanto Fit is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K190757.

When did MAGNETOM Avanto Fit receive FDA 510(k) clearance?

MAGNETOM Avanto Fit received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190757.

Who is the listed applicant for MAGNETOM Avanto Fit?

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

What is the FDA product code for MAGNETOM Avanto Fit?

The FDA product code for MAGNETOM Avanto Fit is LNH.

Other records listing Siemens Medical Solution USA, Inc. as applicant

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.

K220433syngo Application Software (VE21)K201156ARTIS pheno (VE2)K193178Biograph HorizonK190780syngo Application SoftwareK181407Artis zee/zeego & Artis Q/Q.zenK163286ARTIS pheno

View all 8 devices →

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.

↑