FDA Radiology AI Devices

Lunit INSIGHT DBT v1.1 is an AI-powered software designed to assist physicians in detecting and characterizing suspicious breast lesions in digital breast tomosynthesis exams. It marks regions of potential cancer with abnormality scores to aid diagnosis, improving clinical workflow for breast cancer screening in women.

LVivo Software Application is an AI-powered software platform designed to automatically analyze ultrasound images of the heart and bladder. It calculates important functional and structural parameters of the heart's left and right ventricles and the bladder volume, helping clinicians with rapid and accurate assessments during routine echocardiographic exams and point-of-care settings.

QUADSENSE is a surgical tool used during total knee replacement surgery to help surgeons measure and compare the forces in the patellofemoral joint before and after patella resurfacing. The device includes a sensor attached to the patella and displays real-time force data to support surgical decision-making, improving joint alignment and implant positioning.

The Zeta Cranial Navigation System is a stereotaxic image guidance system designed to help neurosurgeons spatially position and orient surgical instruments during cranial surgery. It uses 3D preoperative CT or MRI scans to assist in real-time navigation without requiring rigid fixation of the patient. This system enhances the precision of neurosurgical procedures by providing visual guidance based on medical imaging data.

The Arthrex Virtual Implant Positioning (VIP) System Software is a medical software tool designed to assist surgeons in preoperative planning and precise placement of implants for total shoulder replacement. It processes and displays CT imaging data to help plan and adjust implant positioning, enhancing surgical accuracy and patient outcomes.

MammoScreen BD is an AI-powered software that helps radiologists evaluate breast tissue density in mammograms and digital breast tomosynthesis. It provides breast density categories based on established ACR BI-RADS standards. The tool offers supplementary information to aid radiologists in assessing breast density, supporting better screening decisions for women aged 40 and older. It processes DICOM images and integrates with clinical systems to assist interpretation without replacing physician judgment.

The Versana Premier, Versana Premier Lotus, and LOGIQ F are diagnostic ultrasound systems intended for use by trained healthcare professionals. They provide ultrasound imaging, measurement, display, and analysis for various body regions and clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more, helping clinicians visualize and diagnose conditions through advanced ultrasound technology.

VitruvianScan (v1.0) by Perspectum Ltd is a software medical device designed to analyze MRI images to generate quantitative metrics and composite images for evaluating body fat and muscle composition. It assists trained healthcare professionals by providing non-invasive diagnostic information that supports clinical decisions regarding patient health and wellness.

Definium Pace Select ET is a digital radiography system designed to produce detailed X-ray images of multiple body parts including the skull, spine, chest, abdomen, and extremities for patients of all ages. It features advanced motorized components for positioning and enhances image acquisition with options like image pasting to stitch sequential images, improving workflow and diagnostic capabilities. The system is intended for routine radiography exams and helps clinicians by providing high-quality digital X-ray images that can be easily reviewed and shared.

LungVision is an AI-powered software system that helps clinicians navigate tools within the lungs during procedures. It combines previously acquired 3D CT images with real-time fluoroscopic X-ray images to provide detailed guidance for targeting lung lesions, thus enhancing the precision of pulmonary interventions.