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FDA 510(k)

Magnifico Open (100009900)

K-Number: K251901 · 2026-03-05

ApplicantEsaote, S.p.A.
Decision Date2026-03-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Magnifico Open (100009900) 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 2026-03-05 under 510(k) number K251901. 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 Open (100009900) is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Esaote, S.p.A.. The 510(k) number is K251901.

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

Magnifico Open (100009900) received FDA 510(k) clearance on 2026-03-05, under 510(k) number K251901.

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

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)?

The FDA product code for Magnifico Open (100009900) 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)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

View all 25 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.

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