SonoScape P12 Elite Trolley Color Doppler Ultrasound System

The SonoScape P12 Elite is a trolley-based color Doppler ultrasound system engineered for general imaging, women‘s health, and point-of-care clinical applications, combining single-crystal and composite-crystal transducer technologies, μ-Scan+ and SR Flow imaging, and AI-assisted clinical tools in a compact, battery-backed enclosure designed for space-constrained clinical environments and multi-room mobility.

The P12 Elite Series received FDA 510(k) clearance under K221089 (September 15, 2022) as a Class II ultrasonic pulsed Doppler imaging system (Product Code IYN, 21 CFR 892.1550), following a Traditional Track 3 review. The clearance covers the P12 Elite Series Digital Color Doppler Ultrasound System, which includes the P12 Elite, P12 Exp, P12 Pro, R12, P12N, P11 Elite/Exp/Pro, R11, P11N, P10 Elite/N, R10, P9 Elite, M11, and R9 models. The FDA summary explicitly states “No clinical testing was required. Bench testing only” , including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), acoustic output (IEC 60601-2-37, AIUM/NEMA UD 2), software verification/validation (IEC 62304), and biocompatibility per ISO 10993-5/10. No independent peer-reviewed clinical validation study specific to the P12 Elite was identified in the public literature during preparation of this page.

The imaging chain is anchored by single-crystal convex, intracavity, composite-crystal linear, volume, and phased array transducers—covering an ultra-wide frequency range for abdominal, obstetric, gynecologic, cardiac, vascular, breast, thyroid, and musculoskeletal imaging. The system includes μ-Scan+ for speckle reduction and organ/lesion visibility, SR Flow for low-velocity flow detection, C-xlasto Imaging for quantitative strain ratio analysis, Tissue Doppler Imaging (TDI) for myocardial velocity assessment, Contrast-Enhanced Ultrasound (CEUS) with Dynamic Acoustic Control, and S-Fetus for automated fetal plane acquisition and biometry.

Key Features & Benefits

Single-Crystal and Composite-Crystal Transducer Portfolio

The P12 Elite supports a broad transducer portfolio—single-crystal convex, intracavity, composite-crystal linear, volume, and phased array probes—designed for penetration, sensitivity, and resolution across diverse patient body habitus and clinical applications. The 4 active probe ports support efficient switching between abdominal, cardiac, vascular, and endocavitary examinations without repeated disconnection.

μ-Scan+ and SR Flow for Image Clarity and Hemodynamic Accuracy

μ-Scan+ is a new-generation imaging technology that suppresses speckle artifacts while maintaining real tissue architecture, improving the visibility of organs and lesions with high-definition contrast resolution. SR Flow improves the capability of detecting low-velocity flow signals, enhances spatial resolution, and overcomes flow overflow to present real hemodynamic information.

C-xlasto Imaging for Quantitative Elastic Analysis

C-xlasto Imaging enables comprehensive quantitative elastic analysis, rapidly calculating Strain Ratio for tissue stiffness assessment. It is supported by multiple probes to ensure good reproducibility and highly consistent quantitative elastic results.

Tissue Doppler Imaging and Contrast-Enhanced Ultrasound

Tissue Doppler Imaging (TDI) provides velocities and other clinical information on myocardial functions, supporting the clinician in analyzing and comparing the motions of different parts of the heart. Contrast-Enhanced Ultrasound (CEUS) with Dynamic Acoustic Control technology effectively controls acoustic pressure of the contrast agent, guaranteeing longer contrast agent duration and better lesion perfusion of delayed-phase observation.

S-Fetus and Automated Clinical Tools

S-Fetus, based on a deep learning algorithm, provides a one-step solution for automatic standard plane acquisition and measurement, obtaining common fetal biometry results with one click. The P12 Elite Series includes automated measurement/analysis tools such as Auto OB, Auto NT, Auto EF, Auto Bladder, Auto IMT, and S-Fetus, alongside S-MSK, Sono-Help, Sono-Assistant, and Sono-Synch. These are measurement and workflow aids—the user retains control to edit, accept, or reject automated results, and clinical interpretation remains with the qualified clinician.

WideScan, Real-time Color Panoramic, and Vis-Needle

WideScan enlarges the ultrasound image during real-time scanning using linear or convex probes, providing a more complete view of large lesions or anatomical structures. Real-time Color Panoramic combines color flow with real-time panoramic imaging, enabling visualization of blood flow throughout an entire vein or artery in real time. Vis-Needle uses ultrasound beam steering and deflection to improve needle visualization in tissue, supporting procedural guidance with reduced risk to surrounding structures.

21.5-Inch Monitor, 13.3-Inch Touchscreen, and Detachable Battery

The 21.5-inch HR medical monitor is equipped with a 3D arm featuring tilt, swivel, and height adjustment, with a 23.8-inch HR medical monitor optionally available with 220° rotation. The 13.3-inch tilting touchscreen provides fast and efficient operation alongside a height-adjustable and rotatable control panel and sliding keyboard. The detachable large-capacity battery ensures high flexibility and safety during transport or power interruption, and the multi-stage temperature control gel warmer supports patient comfort.

DICOM 3.0, Wi-Fi, and Workflow Integration

The system includes DICOM 3.0 (Store, Worklist) for PACS and hospital information system integration, alongside integrated Wi-Fi, dual USB 3.0, and DVD-RW for data management and connectivity. Sono-Drop enables wireless image sharing to smartphones, and Sono-Help provides on-screen tutorials with probe placement, anatomy illustrations, and standard image examples for less experienced clinicians.

Technical Specifications

Why Choose the SonoScape P12 Elite?