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

Name: FDA 510(k) clearance K212851
Creator: U.S. Food and Drug Administration
Published: 2022-03-16

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. Device class: 2.

Clearance details

Applicant: Echolight S.P.A
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
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 ↗

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K202514 — EchoS Family2021-02-25
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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.