SC1 Handheld Ultrasound Imaging System (Model: SC1)— 510(k) K210468

Name: FDA 510(k) clearance K210468
Creator: U.S. Food and Drug Administration
Published: 2021-07-23

Substantially Equivalent

Fcu Co., Ltd.

FDA 510(k) clearance K210468 for SC1 Handheld Ultrasound Imaging System (Model: SC1), Substantially Equivalent on 2021-07-23. Applicant: Fcu Co., Ltd.. Device class: 2.

Clearance details

Applicant: Fcu Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2021-02-16
Decision date: 2021-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuseong-Gu, KR

Download summary PDF View on FDA.gov ↗

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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.