510(k) K260589— ES-Series

Substantially Equivalent

E-Scopics

Clearance details

Applicant: E-Scopics
Product code: Code IYN
Advisory panel: Radiology
Date received: 2026-02-20
Decision date: 2026-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Aix-En-Provence, FR

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.