FDA Radiology AI Devices

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.

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.

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.

The OEC One ASD is a mobile C-arm X-ray system designed to provide fluoroscopic and digital spot images during diagnostic, interventional, and surgical procedures across various clinical specialties. It helps clinicians visualize patient anatomy in real-time to aid procedure guidance and decision making. The device uses advanced flat panel detector technology to enhance image quality and supports ease of use with features such as a touchscreen monitor, integrated printer shelf, and improved software architecture.

The FLASH EVD System is a stereotactic image-guided navigation tool designed to assist surgeons in the precise placement of external ventricular drain catheters during neurosurgery. It uses preoperative imaging and real-time tracking to improve accuracy and workflow during procedures that relieve intracranial pressure. This helps surgeons position instruments more accurately without rigidly fixing the patient or instruments.

BioTraceIO Precision (2.0) is a medical software that assists physicians by analyzing ultrasound images captured during liver ablation procedures to visualize and predict the ablation zone. It helps clinicians assess the effectiveness of radiofrequency or microwave ablation treatments by correlating ultrasound data with contrast-enhanced CT scans obtained post-procedure, improving decision-making while providing adjunctive visual information during and after treatment.