SonoScape P10 Trolley Color Doppler Ultrasound System

The SonoScape P10 is a trolley-based color Doppler ultrasound system engineered around a flexibility-first philosophy—designed to provide clinicians with high-quality images, abundant probe selection, various clinical tools, and automatic analysis software within a single mobile console. It is FDA-cleared under 510(k) K173058 (December 1, 2017) as a Class II ultrasonic pulsed Doppler imaging system (Product Code IYN, 21 CFR 892.1550), following a 64-day Traditional review pathway.

The cleared intended use covers Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Cephalic (neonatal and adult), Trans-rectal, Transvaginal, Peripheral Vascular, Cerebral Vascular, Musculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esophageal (Cardiac), Laparoscopic, OB/Gyn, and Urology applications, evaluated by a qualified physician. The FDA summary explicitly states “No clinical testing was required” ; substantial equivalence was supported by laboratory and phantom tests verifying conformity to applicable medical device standards, including electrical safety, biocompatibility, and acoustic output—not by human clinical trials establishing diagnostic accuracy. No independent peer-reviewed clinical validation study specific to the P10 was identified in the public literature during preparation of this page.

The imaging chain is built around Pulse Inversion Harmonic Imaging (PIH) , which fully preserves harmonic wave signal and restores authentic acoustic information to boost resolution and reduce noise; Spatial Compound Imaging, which uses multiple lines of sight for optimal contrast resolution, speckle reduction, and border detection—making the P10 ideal for superficial and abdominal imaging with better clarity and improved continuity of structures; and μ-Scan, which reduces noise, improves boundary signal, and elevates image uniformity. The system supports a broad probe portfolio including convex (3C-A), linear (L741), phased array (3P-A), and endocavitary (6V1) transducers, with a frequency range of 1.0–25.0 MHz across linear, convex, and phased array configurations.

Regulatory status: In addition to FDA 510(k) K173058, distributor documentation references CE marking and ISO 13485 certification for the P10 platform. No CE MDR certificate or China NMPA registration specific to the P10 model name was independently verified during preparation of this page. Availability, labeling, and cleared claims vary by market; confirm local registration and intended use before purchase.

Key Features & Benefits

Pulse Inversion Harmonic Imaging, Spatial Compound Imaging, and μ-Scan

The P10 combines three core image-processing technologies. PIH fully preserves harmonic wave signal and restores authentic acoustic information, boosting resolution and reducing noise for clearer visualization. Spatial Compound Imaging uses multiple lines of sight to achieve optimal contrast resolution, speckle reduction, and border detection—positioning the system for superficial and abdominal imaging with better clarity and improved continuity of anatomical structures. μ-Scan reduces noise, improves boundary signal, and elevates image uniformity for consistent tissue definition across different scanning conditions. These are signal-chain and image-processing specifications—clinical value depends on proper probe selection and clinician review.

SR-Flow, Real-time Panoramic, and WideScan

SR-Flow filters tissue movement from low-velocity blood flow signals more effectively, suppressing overflow to present an excellent blood flow profile—supporting hemodynamic assessment in fine and slow-flow vessels. Real-time Panoramic acquires an extended field of view for large organs or lesions to facilitate diagnosis and measurement during the scan. WideScan enables an expanded view angle for both linear and convex probes, particularly useful for a complete view of large lesions and anatomic structures. These are imaging and workflow capabilities—they support the clinician‘s assessment and do not constitute a diagnosis.

Versatile Probe Portfolio: Convex, Linear, Phased Array, and Endocavitary

The P10 offers a comprehensive probe selection covering abdomen, pediatric, OB/GYN, cardiovascular, musculoskeletal, and small-parts applications. The convex 3C-A is suited for abdomen, gynecology, obstetrics, urology, and even abdomen biopsy; the linear L741 addresses vascular, breast, thyroid, and other small-parts diagnosis, with adjustable parameters for MSK and deep vessels; the phased array 3P-A provides elaborate presets for adult and pediatric cardiology and emergency examinations, even for difficult patients; and the endocavitary 6V1 supports gynecology, urology, and prostate applications, with temperature detection technology that protects the patient and extends probe service life.

Vis-Needle and Specialized Clinical Tools

Vis-Needle uses ultrasound beam steering and deflection to improve needle visualization during ultrasound-guided procedures—supporting procedural confidence and reducing risk to surrounding structures. The system also includes automatic analysis software and measurement packages covering the cleared clinical applications, alongside real-time panoramic and WideScan tools that extend the field of view without requiring probe repositioning.

Mobile Console with Five Probe Connectors and Removable Probe Holders

The P10 is a mobile console with touch screen and keyboard control panel, a color LCD monitor, and optional probes. The configuration includes five probe connectors, removable probe holders, a sliding keyboard, a height-adjustable and rotatable control panel, and a large-capacity built-in battery—supporting multi-probe workflows and operation during power interruption or intra-facility transport. The sensitive touch screen and large monitor support direct, efficient control during examinations.

Broad Clinical Applications

The FDA-cleared indications span fetal, abdominal, pediatric, small-organ (breast, thyroid), cephalic (neonatal and adult), trans-rectal, transvaginal, peripheral vascular, cerebral vascular, musculoskeletal (conventional and superficial), cardiac (pediatric and adult), trans-esophageal (cardiac), laparoscopic, OB/Gyn, and urology applications, with age, weight, health condition, and race unlimited. This breadth allows a single P10 to serve general practice, OB/GYN, cardiology, vascular, and MSK workflows within the cleared scope.

Technical Specifications

Why Choose the SonoScape P10?