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FDA 510(k)

Magnifico Open (100009900); Magnifico MSK ( 100009910)

K-Number: K241133 · 2024-06-26

ApplicantEsaote, S.p.A.
Decision Date2024-06-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Magnifico Open (100009900); Magnifico MSK ( 100009910) 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 2024-06-26 under 510(k) number K241133. 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 (100009900); Magnifico MSK ( 100009910)?

Magnifico Open (100009900); Magnifico MSK ( 100009910) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Esaote, S.p.A.. The 510(k) number is K241133.

When did Magnifico Open (100009900); Magnifico MSK ( 100009910) receive FDA 510(k) clearance?

Magnifico Open (100009900); Magnifico MSK ( 100009910) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K241133.

Who is the listed applicant for Magnifico Open (100009900); Magnifico MSK ( 100009910)?

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 (100009900); Magnifico MSK ( 100009910)?

The FDA product code for Magnifico Open (100009900); Magnifico MSK ( 100009910) 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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