FDA Radiology AI Devices

Brainomix 360 e-Lung is a software tool designed to assist physicians by providing automated, quantitative analysis of chest CT images. It offers 3D segmentation, volumetric measurements, and density evaluations of lung tissue to support diagnosis and longitudinal assessment of lung diseases, enhancing workflow efficiency and accuracy in radiological interpretation of CT thoracic scans.

Brainomix 360 e-ASPECTS is an AI-based software that analyzes non-contrast CT brain scans to help clinicians assess ischemic brain tissue injury and calculate an ASPECTS score, which reflects the extent of stroke-related brain damage. It uses automated image processing and machine learning to highlight affected brain regions, providing decision support for stroke diagnosis and treatment.

The V8 Diagnostic Ultrasound System and its variants are advanced ultrasound imaging devices designed to capture and analyze ultrasound images, including 2D, Doppler modes, and 3D/4D images. They assist healthcare professionals in diagnosing a wide range of medical conditions across various body regions by providing real-time imaging and measurement capabilities with AI-supported features such as nerve tracking and cardiac strain analysis.

Contour ProtégéAI+ is a medical imaging software accessory that leverages machine-learning algorithms to automatically create contours of anatomical structures on CT and MR images. It supports clinicians by automating and assisting in image segmentation, which is critical for adaptive therapy, radiation treatment planning, and patient follow-up. The software provides significant time savings and improves contouring consistency, while allowing clinicians to review and edit results as needed.

TeraRecon Aorta.CT is a software that automatically segments and labels key anatomical landmarks of the aorta from contrast CT Angiography scans. It helps trained medical professionals by providing 3D visualizations and measurements to assist in patient management and procedure planning, without altering the original scan data or providing diagnosis.

CephNinja is a software tool designed for dental professionals to assist in orthodontic treatment planning and case diagnosis by enabling cephalometric tracing and analysis of lateral cephalometric x-ray images. It operates on macOS and iOS platforms, supporting 2D image visualization and detailed landmark digitization but requires interpretation by trained practitioners. The software is not intended for standalone diagnostic use, especially its mobile version.

Rapid Neuro3D is an AI-powered medical software that processes CT angiography scans to provide 3D and 2D visualizations of the brain's arterial blood vessels. It helps physicians confirm the presence or absence of identified lesions and assists in evaluation and treatment planning by simplifying image interpretation.

BioTraceIO Precision (2.0) is a medical software that assists physicians by analyzing ultrasound images captured during liver ablation procedures to visualize and predict the ablation zone. It helps clinicians assess the effectiveness of radiofrequency or microwave ablation treatments by correlating ultrasound data with contrast-enhanced CT scans obtained post-procedure, improving decision-making while providing adjunctive visual information during and after treatment.

The Voluson Expert Series (including models 18, 20, and 22) by GE Healthcare is a range of advanced ultrasound imaging systems designed for use by trained healthcare professionals in hospitals and clinics. They provide high-performance real-time ultrasound imaging and analysis capabilities including 2D, 3D, 4D, color Doppler, power Doppler, pulse wave Doppler, harmonic imaging, elastography, and advanced AI-assisted software for obstetric and gynecologic assessments. This helps clinicians obtain detailed diagnostic images for fetal, abdominal, cardiac, musculoskeletal, and other clinical applications, supporting accurate diagnosis and patient care.

MSKai is a medical software that helps clinicians by automatically identifying, measuring, and reporting features of the lumbar spine from T2 weighted MRI images. It supports radiologists and spine surgeons by providing reliable, repeatable quantitative assessments that can be reviewed and confirmed for clinical use, improving workflow efficiency.