FDA Radiology AI Devices

MammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.

Saige-Dx by DeepHealth, Inc is an AI-powered software that assists radiologists by automatically analyzing DBT mammograms and associated 2D images to detect potential soft tissue lesions and calcifications that might indicate breast cancer. It provides suspicion levels for findings and the entire case to support physicians during screening mammogram interpretation, improving diagnostic accuracy and efficiency.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

ProFound Detection V4.0 is an AI-powered software designed to assist radiologists by detecting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis (DBT) images. It helps identify potential malignant lesions by marking findings and providing confidence scores, thus supporting earlier and more accurate breast cancer detection during image interpretation.

TumorSight Viz is a cloud-based AI software that helps clinicians visualize and analyze breast MRI images in patients with early-stage or locally advanced breast cancer. It processes dynamic contrast-enhanced MRI data to provide 3D renderings, measurements, and segmentations of tumors, supporting more informed clinical evaluations and treatment planning.

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.

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.

MammoScreen 3 is an artificial intelligence software tool designed to assist physicians in interpreting screening mammograms from digital mammography and digital breast tomosynthesis systems. It provides graphical marks indicating suspicious soft-tissue lesions or calcifications, along with a suspicion score and lesion characterization, helping radiologists in their diagnosis and reporting. The software is intended as an aid to, but not a replacement for, the physician's clinical judgment.