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Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications

The SIUI CTS-5500/CTS-6600 is a portable diagnostic ultrasound system capable of the following operating modes: 2D (B mode), M and B/M. The system is designed for use in linear and convex scanning modes and supports linear and convex transducers. The system has cine review, image zoom, measurements and calculations, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

This submission describes a diagnostic ultrasound system (CTS-5500/CTS-6600), not an AI-powered device. Therefore, the provided text does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details relevant to AI device assessment.

The document is a 510(k) premarket notification for a traditional medical device, demonstrating substantial equivalence to a predicate device (SIUI CTS-485, K012772) rather than proving performance against specific acceptance criteria in a clinical study as would be required for a novel AI-driven diagnostic.

Thus, I cannot extract the requested information as it is not present in the provided text.

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