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FDA 510(k)

I-Genius (100019400)

K-Number: K261331 · 2026-07-31

ApplicantEsaote, S.p.A.
Decision Date2026-07-31
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-Genius (100019400) 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 2026-07-31 under 510(k) number K261331. 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 I-Genius (100019400)?

I-Genius (100019400) is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Esaote, S.p.A.. The 510(k) number is K261331.

When did I-Genius (100019400) receive FDA 510(k) clearance?

I-Genius (100019400) received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261331.

Who is the listed applicant for I-Genius (100019400)?

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 I-Genius (100019400)?

The FDA product code for I-Genius (100019400) 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.

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)K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

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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.

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.K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationK251937nordicAudio (1.0)Nordicneurolab AS

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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