HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System— 510(k) K220043

Substantially Equivalent

Samsung Medison Co., Ltd.

FDA 510(k) clearance K220043 for HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System, Substantially Equivalent on 2022-04-05. Applicant: Samsung Medison Co., Ltd..

Clearance details

Applicant: Samsung Medison Co., Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2022-01-05
Decision date: 2022-04-05
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.