SonoScape P60 Exp Trolley Color Doppler Ultrasound System

The SonoScape P60 Exp is a premium trolley-based color Doppler ultrasound system engineered specifically for women‘s healthcare across the care continuum—from reproductive medicine and early pregnancy screening through fetal assessment, pelvic floor evaluation, and breast imaging. It is built on SonoScape’s Wis+ artificial intelligence platform, a deep-learning architecture designed to simplify workflow, enhance measurement reproducibility, and provide consistent biometric results across routine and complex OB/GYN examinations.

The P60 Series received FDA 510(k) clearance under K241949 (January 17, 2025) as a Class II ultrasonic pulsed Doppler imaging system (Product Code IYN, 21 CFR 892.1550) , following a 198-day traditional 510(k) review. A prior clearance under K171000 (July 11, 2017) also covers the P60 Series. The K241949 clearance explicitly incorporates real-world evidence (RWE) , including retrospective and prospective clinical practice data, used for standalone performance testing of the S-Fetus AI feature across 3 hospitals in China. The FDA summary notes the submission followed a standard predicate-based equivalence pathway and did not require clinical trial data for the device clearance itself; the S-Fetus AI performance data was submitted as real-world evidence supporting the AI/ML feature.

The imaging chain is anchored by a premium transducer portfolio—including composite crystal linear probes, single-crystal convex and phased arrays, and specialized transvaginal transducers with a 230° sweeping angle—designed for exceptional acoustic architecture and superior imaging capability in women‘s health exams. Advanced hemodynamic tools include Micro F for slow-flow tiny vessel visualization without contrast agent, and Smart 3D/4D with a high-density volume rendering engine for realistic volumetric imaging.

The P60 Exp is positioned for reproductive medicine, OB exams across all gestational ages, neonatal care, pelvic floor ultrasound, and breast ultrasound. AI-assisted clinical modules include S-Fetus for fully automatic fetal plane detection and biometry in one second; S-Pelvic for automated pelvic floor anatomy recognition, trace, and measurement including levator hiatus assessment in 3D/4D; and 4D HyCoSy with SPI for color-coded contrast-timing visualization of the uterus, fallopian tubes, and ovaries to support tubal patency investigation.

Key Features & Benefits

Wis+ AI Platform with Published Real-World Evidence for S-Fetus

The Wis+ platform uses deep-learning technology to simplify workflow and enhance measurement reproducibility and consistency. The S-Fetus AI feature underwent standalone performance testing using real-world clinical practice data (retrospective and prospective images from 3 hospitals in China) submitted as part of FDA K241949. Performance results: fetal standard section recognition accuracy ≥85% (observed 90.01%, 3717 test images); fetal growth parameter measurement accuracy ≥80% (observed 85%, 2929 test images); and clinical performance non-inferior to manual scanning (158 clinical cases, lower limit of 95% CI for difference > −10%). These are AI performance validation results for specific software features; clinical interpretation remains with the qualified user.

S-Fetus: One-Second Automated Fetal Biometry

S-Fetus is a user-friendly tool that, from a cine loop of the fetal head, extracts standard planes and displays measurement results in one second, reducing keystrokes and working time by several times. It is designed to transform obstetric ultrasound examinations into a faster and more consistent experience, supporting fetal growth assessment across all gestational ages.

S-Pelvic: Automated Pelvic Floor Assessment in 2D and 3D/4D

S-Pelvic provides full automation of pelvic floor anatomy recognition, trace, and measurement with one click. It supports auto anterior compartment evaluation in 2D and auto levator hiatus evaluation in 3D/4D, considering both rest and Valsalva maneuver to cover as many steps and details as possible in pelvic floor ultrasound.

4D HyCoSy with SPI for Tubal Patency Investigation

4D HyCoSy with SPI is a proprietary P60 Exp feature that clearly demonstrates the arrival time of contrast agents into different parts of the uterus, fallopian tubes, and ovaries. This provides clinicians with strong and confident evidence to investigate tubal patency in subfertile female patients. This is a procedural visualization tool—it supports the clinician’s assessment and does not constitute a diagnosis on its own.

Micro F for Slow-Flow Tiny Vessel Visualization Without Contrast

Micro F provides an innovative method to expand the range of visible flow, especially for visualizing slow-flow tiny vessels. By adopting an advanced adaptive filter and accumulating temporal and spatial signals, Micro F distinguishes minute flow from overlaying tissue movement, depicting hemodynamics with higher sensitivity and spatial resolution. This is an imaging capability—clinical value depends on proper probe selection and clinician review.

Smart 3D/4D with High-Density Volume Rendering Engine

The new high-density volume rendering engine of the P60 Exp significantly optimizes signal processing and 3D rendering, delivering high volume rates, exceptional detail, and realistic effect. The comprehensive volume imaging suite extends diagnostic capabilities into endocavity 3D/4D imaging, follicle auto measurement, and multiple 3D rendering modes, supporting assessment of uterine anomalies, endometrium, and tumor morphology.

Specialized Transvaginal Transducers with 230° Sweeping Angle

The specialized transvaginal transducers feature an ingenious crank handle design for comfortable and easy examination operation, alongside a 230° large sweeping angle and dedicated biopsy bracket for clear biopsy needle placement visualization and ultrasound intervention safety.

Breast Health Assessment Suite

The P60 Exp comes with a composite crystal linear probe, Micro F, panoramic imaging, elastography, and intelligent tools designed to fully evaluate breast health. S-Thyroid also supports detection and classification of thyroid lesions based on ACR TI-RADS guidelines with automatic boundary definition and report generation.

Technical Specifications

Why Choose the SonoScape P60 Exp?