EchoSK and EchoSGyn modules for EchoS Family devices— 510(k) K212851

Substantially Equivalent

Echolight S.P.A

FDA 510(k) clearance K212851 for EchoSK and EchoSGyn modules for EchoS Family devices, Substantially Equivalent on 2022-03-16. Applicant: Echolight S.P.A.

Clearance details

Applicant: Echolight S.P.A
Product code: Code IYO
Advisory panel: Radiology
Date received: 2021-09-07
Decision date: 2022-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lecce, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.