S6 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K112602

Substantially Equivalent

Sonoscape Company Limited

FDA 510(k) clearance K112602 for S6 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2011-11-07. Applicant: Sonoscape Company Limited.

Clearance details

Applicant: Sonoscape Company Limited
Product code: Code IYN
Advisory panel: Radiology
Date received: 2011-09-07
Decision date: 2011-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.