FDA Radiology AI Devices

3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

ART-Plan+ (v3.0.0) is an AI-based software platform designed to assist cancer treatment via radiotherapy. It automatically segments organs at risk, lymph nodes, and tumors on CT and MR images and generates radiotherapy treatment plans. These plans are imported into clinicians' Treatment Planning Systems for dose calculation, review, and approval, helping streamline and improve the radiotherapy planning process for trained medical professionals.

JLK-AILink is a software platform designed to help healthcare professionals manage, view, and share medical images from various imaging devices like CT and MRI scanners. It enables efficient processing and annotation of images and supports remote access through mobile devices, enhancing clinical workflows and facilitating timely decision-making for patient care.

Loss of Pulse Detection is a software application from Fitbit designed to analyze pulse data collected by consumer wrist-worn devices to detect possible loss of pulse events. When such events are detected, it alerts the user with audio, visual, and haptic signals, and can prompt an emergency call if the user does not respond. This helps in early identification of critical cardiac events, improving patient safety by notifying potential emergencies.

ExamVue Apex is a flat panel digital X-ray detector system designed for use in general and specialist radiology, including mobile x-ray systems. It captures digital images by converting x-rays to electronic signals, facilitating efficient image acquisition and management without film. The system includes advanced software for image processing, presentation, and storage, helping clinicians to acquire high-quality diagnostic images effectively.

OncoStudio (OS-01) is a software tool that uses deep learning to automatically outline organs at risk in CT scans. This helps clinicians and radiation oncologists efficiently generate contouring for treatment planning by providing initial contours that can be reviewed and confirmed. The software supports multiple anatomic regions including head & neck, thorax, abdomen, and pelvis, and outputs results in DICOM-RT format compatible with radiation therapy systems.

The Green X 12 SE (PHT-40CHS) is a 4-in-1 advanced digital X-ray system for dental imaging that combines panoramic, cephalometric, 3D Cone Beam CT (CBCT) and model scanning capabilities in one device. It helps dentists and healthcare professionals provide detailed diagnostic images of the head, neck, and dental structures, supporting accurate diagnosis and treatment planning for adult and pediatric patients, including orthodontics. This device enhances imaging workflow and diagnostic capabilities by integrating multiple imaging modalities with modern digital detectors and software.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is a system that combines 3D surgical planning software with patient-specific physical guides and models to assist surgeons in facial bone surgeries. It helps surgeons visualize patient anatomy, plan interventions, and accurately carry out surgeries by guiding instruments and bone cutting based on a customized surgical plan created from medical images.

The Paradigm System is a surgical navigation device that helps surgeons accurately place spinal surgical instruments during open procedures. It integrates real-time high-resolution camera images of the surgical site with preoperative CT imagery to create a 3D model of the spine, enabling precise instrument placement and improving surgical accuracy and safety from thoracic to sacrum vertebrae.

The Primus Spinal Fixation System is a spinal fixation device designed to provide stabilization and immobilization for the thoracic, lumbar, and sacral spine regions. It includes screws, rods, and connectors that can be precisely placed with the aid of navigation instruments compatible with the Medtronic StealthStation System, which uses medical imaging data like CT and MRI scans to assist surgeons in accurate screw placement during spinal surgeries.