Voluson™ Performance 16; Voluson™ Performance 18

The Voluson™ Performance 16 and Performance 18 are general-purpose diagnostic ultrasound systems intended for use by qualified healthcare professionals for imaging, measurement, display, and analysis of the human body and fluids. They support multiple clinical applications including fetal/obstetrics, abdominal, pediatric, cardiac, vascular, musculoskeletal, and other specialized imaging modes in hospital or medical clinic settings.

The devices employ the same fundamental scientific technology as their predicate devices and support identical transducers (linear, curved linear, and matrix phased array). They include multiple imaging modes (B, M, Doppler, 3D/4D, elastography, contrast) and incorporate migrated AI software features (SonoPelvicFloor 3.0, SonoAVCfollicle 2.0, Fibroid Mapping, SonoLyst Live) and other software features (O-RADS, Voice Control, Vscan Air Probe Support) from previous cleared models, with no changes to algorithmic flow or AI inference components.

Devices comply with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20 (DICOM), IEC 62359 (thermal and mechanical indices), and AAMI TIR69:2017. Testing included risk analysis, design reviews, module verification, system integration testing, performance testing, and safety testing; materials were evaluated for biocompatibility.

The devices are substantially equivalent because they are intended for identical diagnostic ultrasound imaging and fluid flow analysis as the Voluson SWIFT predicate, employ the same clinical applications and similar imaging modes (minus B-Flow), use identical transducers and comparable measurement/reporting capabilities, meet applicable safety standards, and maintain acoustic power levels below FDA limits. Migrated AI and software features were already cleared on their respective applicable probes with no algorithmic changes; regression testing confirmed their functionality on the new systems.