FDA 510(k)

Magnifico Open (100009900)

K-Number: K251901 · 2026-03-05

Decision Date2026-03-05

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

When was Magnifico Open (100009900) approved by the FDA?

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

What company makes Magnifico Open (100009900)?

Magnifico Open (100009900) is manufactured by Esaote, S.p.A..

What is the FDA product code for Magnifico Open (100009900)?

The FDA product code for Magnifico Open (100009900) is LNH.

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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.