510(k) K220169— SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Substantially Equivalent

Bionet Co., Ltd.

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2022-01-20
Decision date: 2022-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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.