POST-MARKET CLINICAL FOLLOW-UP STUDY OF THE COLOR DOPPLER ULTRASOUND SYSTEM: A PROSPECTIVE, COMPARATIVE EVALUATION OF SAFETY AND PERFORMANCE

Background: Post-market clinical follow-up (PMCF) studies are essential for verifying the real-world safety and performance of medical devices. This study evaluated the ViV 80 Color Doppler Ultrasound System (Zoncare) against the Model R**7 from a well-established manufacturer (M** company) in routine clinical practice. Methods: A prospective, observational, single-center study was conducted at Maternal and Child Health Hospital of Hubei Province, China. A total of 363 cases (140 male, 223 female) underwent abdominal, thyroid, cardiac, and gynecologic examinations using four probe types (convex, linear, phased array, volume). Endpoints included image consistency (target ≥95%), positive detection rate, and adverse events. Results: Image Consistency: All probes met the 95% target (convex: 97%; linear: 100%; phased array: 95%; volume: 96%). Moreover, mean image quality scores were consistently high, with the ViV 80 performing comparably or superiorly to the R**7 in each body site; Detection Rates: Varied by anatomy (liver: 44%; thyroid: 31%; cardiac: 8%; uterus: 26%), reflecting clinical heterogeneity; Adverse Events: No device-related adverse events occurred; five cases reported transient pressure sensations (1.4%). Conclusion: The ViV 80 demonstrated non-inferiority to the R** 7 in image quality and safety, supporting its continued use in diverse clinical applications.