S12 Digital Color Doppler Ultrasound System— 510(k) K142474

Substantially Equivalent

Sonoscape Company Limited

FDA 510(k) clearance K142474 for S12 Digital Color Doppler Ultrasound System, Substantially Equivalent on 2014-12-19. Applicant: Sonoscape Company Limited.

Clearance details

Applicant: Sonoscape Company Limited
Product code: Code IYN
Advisory panel: Radiology
Date received: 2014-09-03
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.