Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

The Voluson Expert 18, 20, and 22 are full-featured ultrasound systems intended for diagnostic imaging across multiple clinical applications including fetal/OB, abdominal, cardiac, vascular, and musculoskeletal imaging. They support various imaging modes (B, M, Doppler, Color Doppler, 3D/4D, Elastography) and are designed for use by qualified healthcare professionals in hospitals or medical clinics.

The systems employ the same fundamental scientific technology as their predicate devices and maintain identical intended use, imaging modes, and transducer equivalence. New additions include the RAB7-D probe (incremental improvement over RAB6-D), wireless Vscan Air probes, and updated/new AI software features (SonoLyst 1st Trimester, Sono Pelvic floor 3.0 with MHD and anal sphincter detection, O-RADS, and OTI live automation). All models have acoustic power levels below FDA limits and comply with applicable safety standards.

IEC 60601-1 Edition 3.2, IEC 60601-1-2 Edition 4.1, IEC 60601-2-37:2015, ISO 10993-1:2018, ISO 14971:2019, NEMA PS 3.1-3.20 (DICOM), AAMI TIR69:2017, and IEC 62359 Edition 2.1 for thermal and mechanical indices.

The proposed system is substantially equivalent because it maintains the same clinical intended use and imaging capabilities as the predicate K231965 Voluson Expert 18/20/22, with only incremental software improvements and new probes that are either equivalent to or improvements of existing predicates. The new AI features (SonoLyst, Sono Pelvic floor, O-RADS) have been validated with testing demonstrating success rates meeting or exceeding 70% on good image quality datasets and 60% on challenging datasets, consistent with expert-reviewed clinical adequacy standards. The device complies with all applicable safety and performance standards, materials are biocompatible, and no clinical studies were required to establish substantial equivalence.