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-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-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.