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FDA 510(k)

Magnifico Open, Magnifico MSK

K-Number: K212419 · 2022-02-04

ApplicantEsaote, S.p.A.
Decision Date2022-02-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Magnifico Open, Magnifico MSK is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212419. 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 Magnifico Open, Magnifico MSK?

Magnifico Open, Magnifico MSK is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Esaote, S.p.A.. The 510(k) number is K212419.

When did Magnifico Open, Magnifico MSK receive FDA 510(k) clearance?

Magnifico Open, Magnifico MSK received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212419.

Who is the listed applicant for Magnifico Open, Magnifico MSK?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magnifico Open, Magnifico MSK?

The FDA product code for Magnifico Open, Magnifico MSK is LNH.

Other records listing Esaote, S.p.A. 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.

K261331I-Genius (100019400)K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

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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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