HS50 / HS60 Diagnostic Ultrasound System— 510(k) K181336

Substantially Equivalent

Samsung Medison Co., Ltd.

FDA 510(k) clearance K181336 for HS50 / HS60 Diagnostic Ultrasound System, Substantially Equivalent on 2018-12-04. Applicant: Samsung Medison Co., Ltd..

Clearance details

Applicant: Samsung Medison Co., Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2018-05-21
Decision date: 2018-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hongcheon-Gun, KR

Download summary PDF View on FDA.gov ↗

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.