FDA Radiology AI Devices

The Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.

The V5 and H5 series diagnostic ultrasound systems from Samsung Medison are advanced ultrasound imaging devices that provide real-time images and Doppler analysis to assist healthcare professionals in clinical diagnosis across a broad range of applications including obstetrics, cardiology, musculoskeletal, and dermatology. These systems use AI-powered tools for tasks like view recognition, segmentation, and measurement, enhancing accuracy and efficiency in ultrasound examinations.

AutoContour (Model RADAC V4) by Radformation, Inc. is a software tool designed to automatically contour anatomical structures on CT and MR images to aid radiation treatment planning. Using machine learning, it helps clinicians create accurate contours of organs and tissues, streamlining the preparation process for radiation therapy and improving planning precision.

The Digital Radiography System (ManntiX B, ManntiX K) by Shenzhen Browiner Tech Co., Ltd is a portable digital X-ray system designed to acquire high-quality X-ray images of various parts of the patient's anatomy including head, spine, chest, abdomen, pelvis, and extremities. It supports different digital detectors and image processing systems to assist clinicians in obtaining and viewing diagnostic images conveniently. It helps physicians and technicians capture diagnostic X-ray images efficiently in diverse clinical settings.

CDM Insights is a software tool that helps trained healthcare practitioners analyze brain MRI scans of adults over 45 years old. It automatically segments and quantifies brain structures and white matter hyperintensities, compares findings with normative data from healthy populations, and provides easy-to-understand visual and numerical reports. This aids clinicians in evaluating neurological conditions more accurately and efficiently.

DrAid™ for Liver Segmentation is a web-based AI software that assists healthcare professionals in analyzing liver images from CT scans. It generates semi-automated liver segmentation and allows physicians to manually refine these segmentations and identify lesions, aiding in evaluation and treatment planning without providing direct diagnosis.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.

PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.