DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER— 510(k) K110841

Substantially Equivalent

Shantou Institute of Ultrasonic Instruments (Siui

FDA 510(k) clearance K110841 for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER, Substantially Equivalent on 2011-04-15. Applicant: Shantou Institute of Ultrasonic Instruments (Siui.

Clearance details

Applicant: Shantou Institute of Ultrasonic Instruments (Siui
Product code: Code IYN
Advisory panel: Radiology
Date received: 2011-03-25
Decision date: 2011-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Shantou, CN

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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.