DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA— 510(k) K061429

Substantially Equivalent

Esaote, S.p.A.

FDA 510(k) clearance K061429 for DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA, Substantially Equivalent on 2006-07-25. Applicant: Esaote, S.p.A..

Clearance details

Applicant: Esaote, S.p.A.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2006-05-23
Decision date: 2006-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.