K101008

Substantially Equivalent

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

Applicant: Shantou Institute of Ultrasonic Instruments (Siui
Product code: ITX
Advisory panel: Radiology
Date received: 2010-04-12
Decision date: 2010-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.