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FDA 510(k)

SIGNA Artist Evo

K-Number: K213603 · 2022-02-11

ApplicantGe Healthcare (Tianjin) Company Limited
Decision Date2022-02-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA Artist Evo is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K213603. 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 SIGNA Artist Evo?

SIGNA Artist Evo is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K213603.

When did SIGNA Artist Evo receive FDA 510(k) clearance?

SIGNA Artist Evo received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213603.

Who is the listed applicant for SIGNA Artist Evo?

The FDA 510(k) record lists Ge Healthcare (Tianjin) Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNA Artist Evo?

The FDA product code for SIGNA Artist Evo is LNH.

Other records listing Ge Healthcare (Tianjin) Company Limited 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.

K233728SIGNA ChampionK223439SIGNA VictorK211980SIGNA PrimeK202238SIGNA ArtistK192426Signa Voyager, Signa Voyager Quantum

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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