FDA Radiology AI Devices

DeepContour (V1.0) is a software tool that uses deep learning to automatically segment organs on CT images for radiation therapy planning. It helps trained healthcare professionals by generating and editing organ contours, performing 3D reconstruction, and analyzing anatomical structures. By automating these tasks, it improves workflow efficiency and supports precise radiation treatment planning.

The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.

Ethos Treatment Management 3.0 and Ethos Treatment Planning 2.0 from Varian Medical Systems are software applications designed to assist clinicians in managing, generating, and modifying radiation therapy treatment plans. They incorporate AI-based segmentation algorithms to aid in contouring anatomical structures to improve and streamline radiation therapy planning and monitoring. These tools help improve accuracy and efficiency in radiation treatment for cancer and other diseases requiring radiation therapy.

uMR Jupiter is a 5 Tesla superconducting MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It generates detailed anatomical and functional images of the head, body, and extremities to assist clinical diagnosis. The device features advanced AI-accelerated image reconstruction technology, enhancing image quality and scan speed, supporting clinicians in making accurate and timely diagnoses.

Sonio Detect is an AI-powered software designed to assist healthcare professionals during fetal ultrasound exams by automatically identifying various fetal anatomical views and structures, and verifying the quality and characteristics of these images in real-time. This helps ensure that ultrasound examinations are complete and meet established protocols, potentially improving accuracy and efficiency in prenatal care.

syngo.via RT Image Suite is a software tool designed to assist clinicians in viewing, manipulating, and contouring 3D and 4D medical images from various modalities such as CT, PET, MRI, and CBCT. It helps prepare radiation therapy treatment plans by enabling visualization, semi-automatic and automatic contouring of tumors and organs, image registration, and image fusion. The software improves workflow efficiency and treatment accuracy in radiation oncology.

InVision Precision LVEF is a software tool that analyzes previously acquired transthoracic cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, helping clinicians with cardiac evaluation. The software processes DICOM ultrasound videos, uses machine learning to segment the left ventricle, and allows clinicians to review and adjust the measurements for precise cardiac function assessment.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that include innovative AI-powered software features. The Smart View Select software automatically selects optimal heart images for analysis, while the Segmental Wall Motion software evaluates the movement of specific regions of the heart's left ventricle. These tools help clinicians perform more efficient and precise cardiac assessments, enhancing diagnosis and treatment planning.

Rapid by iSchemaView Inc. is a medical image processing software designed to help clinicians analyze CT and MRI images, including functional and dynamic datasets like CT Perfusion and diffusion-weighted MRI. It facilitates quick visualization, quantification, and interpretation of brain tissue changes often seen in acute stroke, helping physicians select patients for endovascular thrombectomy and assess cerebral hemodynamics. The software supports both standard and C-arm CT images and assists in managing complex imaging data efficiently, enhancing clinical workflow and patient care in neurological emergencies.