FDA Radiology AI Devices

The Digital Radiography X-ray System by Shenzhen SONTU Medical Imaging Equipment Co. is a modular digital X-ray system used in hospitals and clinics. It produces high-quality digital images of the whole body, including skull, chest, abdomen, and extremities, helping clinicians diagnose a wide range of conditions. The system supports various patient positions and utilizes digital detectors to convert X-rays into image signals quickly and accurately, enhancing clinical workflow and patient care.

Brainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.

Clarify DL is a software solution that uses deep learning integrated with iterative image reconstruction techniques to reduce noise and improve image quality in Nuclear Medicine bone SPECT images. It helps clinicians by enhancing image clarity which potentially improves diagnostic confidence and patient outcomes.

The INNOVISION-EXII is a stationary digital radiography X-ray system designed for obtaining radiographic images of various anatomical parts of the human body in clinical environments. It supports imaging for both pediatric and adult patients, converting X-ray signals into digital DICOM images to assist clinicians in diagnostic screening. The system incorporates imaging software for processing images and is operated by trained radiologic technologists. It is suitable for imaging areas such as head, spine, chest, and abdomen and is not intended for mammography, angiography, interventional, or fluoroscopy uses.

JLK-ICH is an AI-powered software that analyzes non-contrast CT scans of the head to detect suspected intracranial hemorrhage. It provides automated notifications to clinicians to prioritize review, allowing faster communication and potentially improving patient outcomes. The software works alongside standard care without replacing diagnostic evaluations.

syngo.CT Dual Energy is a post-processing software application for CT scans that uses dual-energy imaging techniques combining low and high energy X-ray spectra to enhance visualization of different materials in the body. It helps clinicians by providing advanced imaging features for better evaluation of anatomical structures and pathologies, including brain hemorrhage visualization, lung perfusion, kidney stone analysis, and more, improving diagnostic accuracy without requiring additional scans.

Ezra Flash is a software device that improves the quality of MRI images of the head, abdomen, and pelvis by reducing noise using advanced neural network algorithms. It processes images from 1.5T and 3T Siemens and GE MRI scanners, helping clinicians get clearer images to support more accurate diagnoses without additional scanning time.

Ortho AI is a medical software device that helps orthopedic surgeons by using AI to semi-automatically measure lengths, angles, and implant positions on radiographic images. It assists in preoperative and intraoperative planning for hip, knee, and lumbar spine surgeries through digital annotations and measurements, improving surgical planning accuracy and efficiency.

The Rist Radial Access Catheter family consists of single lumen catheters designed to provide access to peripheral, coronary, and neuro vasculature. These catheters assist clinicians in delivering interventional devices and diagnostic agents, particularly in neurovascular procedures, improving access with features like hydrophilic coatings and radiopaque markers for better visualization under fluoroscopy.

The 8MP Color LCD Displays (models C811W, C811WT, PA27, PA27T) are high-resolution color LCD screens designed to display digital images of histopathology slides for primary diagnosis. They aid pathologists by providing stable, calibrated, and precise image visualization from validated whole-slide imaging systems, assisting in the interpretation of digital pathology images.