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Technology Development of Diagnostic Ultrasound System for Obstetric Imaging
Sponsor: United Imaging Healthcare North America, Inc.
Summary
This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-05-06
Completion Date
2026-09-30
Last Updated
2026-05-15
Healthy Volunteers
Yes
Conditions
Interventions
Diagnostic Ultrasound System
Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.
Locations (1)
OHSU Perinatology and Genetics Clinic
Portland, Oregon, United States