I-Genius (100019400)— 510(k) K261331
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K261331 for I-Genius (100019400), Substantially Equivalent on 2026-07-31. Applicant: Esaote, S.p.A.. Device class: 2.
Summary
Esaote's I-Genius (100019400) is filed under LNH, nuclear magnetic resonance imaging systems. The record lists 100019400 alongside the name but gives no specs.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Esaote filed from Genoa, Italy. Review took 100 calendar days (April 22 to July 31, 2026).
Clearance details
- Applicant
- Esaote, S.p.A.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Genoa, IT
Recent devices under product code LNH
view allMore clearances from Esaote, S.p.A.
view all- K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- K260746 — S-scan Open (100001800)
- K251901 — Magnifico Open (100009900)
- K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
- K243253 — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.