Technology Development of Diagnostic Ultrasound System for Obstetric Imaging
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.
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Pregnant persons age 18-45 years 2. Single intrauterine pregnancy 3. Gestational duration: 18 - 28 weeks Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.). 2. Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic interve…
Interventions
- DeviceDiagnostic Ultrasound System
Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.
Location
- OHSU Perinatology and Genetics ClinicPortland, Oregon