FDA Radiology AI Devices

JLK-SDH is an AI-powered software that analyzes non-contrast CT head images to detect suspected subdural hemorrhage (SDH). It assists radiologists by notifying them of potential cases in a parallel workflow to standard care, enabling quicker communication and prioritization for specialist review. This helps clinicians promptly identify and manage patients with SDH, improving workflow efficiency and potentially patient outcomes. The device is intended for notification purposes only and does not replace diagnostic evaluation.

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.

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.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

JLK-CTP is an image processing software that helps trained medical professionals analyze brain CT perfusion images. It automatically receives, processes, and visualizes dynamic CT perfusion datasets to calculate blood flow and volume parameters, aiding in the assessment of cerebral blood flow and tissue status in brain imaging.

JBS-LVO is an AI-powered radiological software tool designed to analyze CT angiograms of the brain to detect suspected large vessel occlusions (LVOs). It notifies neurovascular specialists quickly via mobile app notifications to aid in rapid patient triage, supporting timely treatment decisions. The software provides compressed preview images for informational purposes, while diagnosis is made by specialists reviewing full-resolution scans.

Medihub Prostate is a semi-automatic image processing software designed for analyzing prostate MR images. It uses AI to outline the prostate region semi-automatically and supports radiologists and urologists in reviewing MR data. The software requires user editing and confirmation, enhancing the accuracy of prostate volume measurements and analysis, aiding clinical decision-making without replacing the expert's judgment.