FDA Radiology AI Devices

QOCA image Smart CXR Image Processing System is an AI-powered software that analyzes adult chest X-rays automatically to identify suspected pneumothorax cases. It integrates with hospital PACS to notify radiologists so they can prioritize reviewing urgent cases, thus enhancing workflow efficiency. It is not a standalone diagnostic tool, but a triage aid.

Clarius AI is software integrated with the Clarius Ultrasound Scanner that uses artificial intelligence to semi-automatically measure tendon thickness on ultrasound images of musculoskeletal structures such as the Achilles’ tendon and patellar tendon. It helps healthcare professionals by segmenting ultrasound images and automatically placing measurement calipers, streamlining the quantification process while allowing manual adjustment by trained clinicians.

TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.

MR Diffusion Perfusion Mismatch V1.0 by Olea Medical is an AI-powered software tool that automatically processes MR Diffusion and Perfusion imaging data to compute parametric maps, extract volume metrics, and calculate mismatch volumes. It assists radiologists and surgeons by providing quantitative imaging data that supports clinical decision-making. The software integrates with medical image platforms to streamline workflow without altering the original images and is intended to be used alongside other clinical information, not as a standalone diagnostic tool.

AIBOLIT 3D+ is a web-based software system that processes CT and MR medical images to create detailed 2D and 3D visualizations of anatomical structures. It assists healthcare professionals in surgical planning, training, and intraoperative reference by turning multi-dimensional images into easy-to-view and manipulate anatomical models, with color-coded organ identification to improve clinical decision-making.

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.

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.