SONON Ultrasound Imaging System, Model: 300L— 510(k) K170085

Substantially Equivalent

Healcerion Co., Ltd.

FDA 510(k) clearance K170085 for SONON Ultrasound Imaging System, Model: 300L, Substantially Equivalent on 2017-10-12. Applicant: Healcerion Co., Ltd..

Clearance details

Applicant: Healcerion Co., Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2017-01-10
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, 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.