ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE  Diagnostic Ultrasound System

The ACUSON family of diagnostic ultrasound systems (Sequoia, Select, Origin, Origin ICE) provides comprehensive multi-application imaging by utilizing a suite of ultrasound modalities including 2D, Doppler, elastography, and 3D/4D imaging. These systems are designed for diverse clinical evaluations, featuring specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for hepatic steatosis assessment (now including pediatrics) and catheter-based intracardiac echocardiography for interventional guidance, aiming to deliver enhanced diagnostic information and quantitative data.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE systems are versatile, software-controlled diagnostic ultrasound platforms designed to generate images and signals from within the body for a wide array of clinical applications. These applications include fetal, abdominal, pediatric, neonatal cephalic, small parts, OB/GYN, cardiac, pelvic, vascular, adult cephalic, musculoskeletal, and peripheral vascular imaging. Notably, the Sequoia and Sequoia Select models feature an Ultrasonically-Derived Fat Fraction (UDFF) tool, recently expanded for pediatric use, to aid in managing hepatic steatosis. The Origin and Origin ICE systems are further specialized for intracardiac and intraluminal visualization, supporting cardiac interventional procedures through catheter-based imaging with new AcuNav Crystal and SOUNDSTAR Crystal catheters. All systems offer comprehensive anatomical measurement and calculation packages to assist clinicians in diagnosis. These systems employ a range of ultrasound operating modes, such as 2D, M-mode, Color Flow Doppler, Pulsed and Continuous Wave Doppler, Harmonics Imaging, and 3D/4D volume imaging; the Sequoia and Select models also offer elastography (Strain and Shear Wave). The technology is built upon existing Siemens platforms, incorporating enhancements like a 3D Data Converter and new Wi-Fi modules for improved user experience. The expansion of the UDFF tool for pediatric patients was supported by performance data demonstrating acceptable clinical accuracy (AUROC ≥ 0.87 against MRI-PDFF) and reliability (ICC ≥ 0.97) in a cohort of 105 children aged 8-17, with exam times under 60 seconds, using an unchanged algorithm. The Origin ICE model is a variant of the Origin system, largely identical in software and hardware, but with specific transducer compatibility for its intended cardiac applications.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. Beyond AUROC and ICC, what were the sensitivity, specificity, and predictive values of the UDFF tool for detecting clinically significant hepatic steatosis (MRI-PDFF > 5%) in the pediatric cohort, and how do these compare to adult performance?; What are the specific differences in image acquisition parameters or post-processing capabilities between the ACUSON Origin ICE and the standard ACUSON Origin when utilizing the new AcuNav Crystal and SOUNDSTAR Crystal catheters for intracardiac visualization?; How does the '3D Data Converter' facilitate data export (e.g., file formats, compatibility with third-party analysis software), and are there differences in its implementation between the Sequoia/Select and Origin/Origin ICE lines?; What is the range of depths and field-of-view achievable with the new AcuNav Crystal and SOUNDSTAR Crystal catheters, and how do these specifications influence their suitability for various intracardiac structures and patient sizes (pediatric vs. adult)?; Are there any specific performance differences or limitations when using the various imaging modes (e.g., Color Doppler, Harmonics) in pediatric patients with the Sequoia/Select systems compared to adult applications, particularly regarding resolution and penetration?