FDA Radiology AI Devices

The MR 5300 and MR 7700 R11 MR Systems by Philips are advanced magnetic resonance imaging (MRI) devices that provide high-quality images of the internal structures of the head, body, or extremities. These systems help clinicians by enabling detailed visualization, which supports diagnosis, therapy planning, and interventional procedures. The devices incorporate updated software (R11) and minor hardware enhancements, including AI-powered SmartSpeed features that improve image acquisition and reconstruction, facilitating faster and more accurate MRI scans.

AVIEW is a medical imaging software by Coreline Soft that helps clinicians analyze CT scans of the lungs and heart. It automatically segments lung structures, characterizes lung nodules with detailed measurements, and provides calcium scoring of coronary arteries to assess cardiovascular risk. It integrates with AI-based CAD tools and offers cloud and mobile access, making it easier and faster for doctors to diagnose lung and heart conditions.

The Philips CT 3500 is a computed tomography X-ray system designed to produce detailed images of the head, whole body, cardiac, and vascular regions. It supports diagnostic imaging and low dose lung cancer screening using advanced imaging features and includes AI-based image reconstruction for improved image quality at reduced dose, helping clinicians with early detection and diagnosis.

BrainInsight is an automated software that processes low-field MRI brain images to provide automatic labeling, spatial measurement, and volumetric quantification of brain structures. It produces annotated and segmented brain images with color overlays and detailed reports, helping clinicians assess brain anatomy and abnormalities efficiently, particularly using low-field MRIs.

Saige-Density is a medical software that uses AI deep learning techniques to analyze digital mammograms, producing breast density categories based on ACR BI-RADS guidelines. It helps radiologists assess breast tissue composition by providing adjunctive information, improving breast cancer risk assessment and screening interpretation.

Overjet Calculus Assist is a software tool that helps dentists detect calculus deposits on dental X-rays by automatically highlighting suspicious areas. It supports dentists in diagnosis by providing visual cues on bitewing and periapical radiographs, improving sensitivity to calculus without replacing clinical judgment.

The Swoop Portable MR Imaging System by Hyperfine is a bedside MRI device that allows clinicians to capture magnetic resonance images of the head without moving the patient. It utilizes advanced deep learning-based image reconstruction to improve image quality, reducing noise and blurring. This portable device helps provide timely diagnostic information in critical care settings where traditional MRI is difficult.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing chest and abdominal CT scans to detect and flag suspected vertebral compression fractures. It helps prioritize medical images for review, enabling faster triage without altering original images or workflows, thus improving the efficiency of radiological diagnosis and patient care.

The STAR Apollo Mapping System is a software tool designed to help physicians analyze detailed electrical and anatomical heart maps collected during cardiac procedures for atrial fibrillation. By processing data from mapping catheters and displaying key activation patterns in the atria, it provides supplementary information that may assist clinicians in identifying areas of irregular heart activation, although its clinical significance is not yet established.

The Avenda Health AI Prostate Cancer Planning Software is an AI-driven tool that assists physicians by segmenting prostate MR images, evaluating and quantifying lesions, and planning diagnostic or interventional procedures such as biopsies or tissue ablation. It provides a cancer probability map and confidence scores to help clinicians accurately characterize prostate cancer lesions, improving workflow efficiency and decision making in prostate cancer care.