S-scan Open (100001800)— 510(k) K260746
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K260746 for S-scan Open (100001800), Substantially Equivalent on 2026-03-27. Applicant: Esaote, S.p.A.. Device class: 2.
Summary
Esaote's S-scan Open (100001800) is filed under LNH, nuclear magnetic resonance imaging systems. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1000. It was a Special 510(k), and Radiology is both the classification panel and the review panel.
Esaote filed from Genoa, Italy. The decision came 21 calendar days after FDA received it (March 6 to March 27, 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
- Special
- Location
- Genoa, IT
Recent devices under product code LNH
view allMore clearances from Esaote, S.p.A.
view all- K261331 — I-Genius (100019400)
- K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- 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.