FDA Radiology AI Devices

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.

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.

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.

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.

QuickRad is a web-based PACS (Picture Archiving and Communication System) designed for radiology centers and hospitals. It manages and displays medical images from various scanners including CT, MRI, ultrasound, and X-ray, and allows users to integrate FDA-cleared AI models to assist radiologists by visualizing AI outputs alongside images. This helps clinicians by improving workflow efficiency and providing advanced image viewing and reporting tools.

ScanDiags Ortho L-Spine MR-Q is an AI-powered software tool that processes previously acquired lumbar spine MRI images to provide quantitative measurements of spinal anatomical structures such as vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. It utilizes deep learning algorithms for semi-automatic segmentation and measurements, allowing radiologists to review and adjust results. This tool helps clinicians save time and improve the accuracy of lumbar spine assessment without replacing their expert interpretation.

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.

Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It helps healthcare professionals identify potential issues in fetal development, improving diagnostic accuracy and supporting better patient management decisions.

The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems by Edan Instruments are advanced ultrasound imaging devices used by clinicians for a wide range of clinical applications including abdominal, cardiac, musculoskeletal, and vascular imaging among others. These systems support multiple imaging modes such as B mode, Doppler, harmonic imaging, elastography, and contrast imaging, aiding healthcare professionals in acquiring and interpreting ultrasound data to diagnose and monitor patient conditions effectively.