FDA 510(k)

S-scan Open (100001800)

K-Number: K260746 · 2026-03-27

Decision Date2026-03-27

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

S-scan Open (100001800) is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2026-03-27 under approval number K260746. 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 S-scan Open (100001800)?

S-scan Open (100001800) is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Esaote, S.p.A.. The 510(k) number is K260746.

When was S-scan Open (100001800) approved by the FDA?

S-scan Open (100001800) received FDA 510(k) clearance on 2026-03-27, under approval number K260746.

What company makes S-scan Open (100001800)?

S-scan Open (100001800) is manufactured by Esaote, S.p.A..

What is the FDA product code for S-scan Open (100001800)?

The FDA product code for S-scan Open (100001800) is LNH.

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Related Devices (Code: 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.