Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

The Venus Ultimate-Dual, Venus Ultimate-Hepa, and Venus Ultimate-Uro are diagnostic ultrasound systems intended for adults undergoing abdominal, superficial organ, trans-rectal, musculoskeletal, peripheral vessel, and urology examinations. These general-purpose systems are designed for use by qualified healthcare professionals in hospitals and medical clinics to perform ultrasound imaging, measurement, and display of the human body and fluids.

The subject devices support B, B+C, B+C+D(PW), B+M, Image Fusion, and Needle Line modes, with a 24-inch multi-directional LCD monitor and 17-inch touch display. They include convex-array, linear-array, and intracavitary tracked probes. The predicate device (Resona R9S) offers additional modes such as Power Doppler, 3D/4D imaging, and contrast imaging, but the subject device's core imaging modes and fusion/biopsy guidance functions are substantially aligned with the predicate.

Testing per ANSI AAMI ES60601-1:2005 (medical electrical equipment safety), IEC 60601-2-37:2007+A1:2015 (ultrasonic equipment), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 62359:2010+A1:2017 (acoustic output measurement), NEMA UD 2-2004 (acoustic output), ISO 10993-1:2018 (biocompatibility), ISO 17664-1:2021 (device processing), ISO 14971:2019 (risk management), and IEC 62304:2006/Amd 1:2015 (software lifecycle).

The subject device's intended use for abdominal, superficial organ, trans-rectal, musculoskeletal, peripheral vessel, and urology exams overlaps substantially with the predicate's approved indications in those same categories. Although the predicate supports additional clinical applications (obstetrics, cardiology, vascular, fetal imaging) not claimed by the subject device, the differences are in narrower intended use rather than fundamental technology—both employ the same core B-mode and Doppler imaging architectures, Image Fusion, and biopsy guidance. The subject device's narrower scope does not introduce new safety or effectiveness concerns for the claimed indications.