Digital Color Doppler Ultrasound System (P60 Series)

The P60 Series Digital Color Doppler Ultrasound System is a general-purpose diagnostic ultrasound imaging system for hospital use by trained healthcare professionals. It evaluates fetal, abdominal, cardiac, vascular, musculoskeletal, and other anatomical regions using multiple imaging modes including B-mode, Doppler, color flow, 3D/4D, elastography, and contrast imaging.

The P60 Series adds new probes (L752, L2-9, L3-11, MC1-6, 3P-A, 2P1), new biopsy brackets, migrated features from prior predicate devices (SR Flow, Micro F, S-Follicle, S-Endo, S-MSK, VCI, FreeVue, STIC, S-Spine, etc.), and introduces S-FetusAI—an AI/machine learning feature for automated fetal standard section recognition and measurement. Three additional auto-measurement features (S-Breast, S-Thyroid, S-hip) are non-AI equivalents of existing manual measurements.

AAMI/ANSI ES 60601-1 (Edition 3.2, 2021), IEC 60601-1-2 (Edition 4.1, 2020), IEC 60601-2-37 (Edition 2.1, 2015), ISO 10993-1 (2018), and AIUM/NEMA UD 2 (Revision 3, 2009) for acoustic output measurement.

The P60 Series shares identical intended use, imaging modes, and acoustic output levels with the primary predicate device P60 Series (K171000) and meets the same safety standards. While it adds new probes and features, most features are migrated from previously cleared predicate devices (S90 Exp K222596 and P20 Elite K221140). The novel S-FetusAI feature was validated through standalone performance testing (90.01% recognition accuracy, 85% measurement accuracy) and clinical trials demonstrating non-inferiority to manual scanning. These performance data show that the technological differences do not raise distinct safety or effectiveness questions.