United Imaging Healthcare North America, Inc.
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.
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…
Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.
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