FDA Radiology AI Devices

Heuron ICH is an artificial intelligence software that assists medical specialists by analyzing non-contrast head CT images to identify suspected cases of intracranial hemorrhage. It provides notifications and compressed preview images to help prioritize patient care and streamline workflow, without modifying the original images or serving as a diagnostic device.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is an AI-powered software that automatically analyzes CT angiography scans of the chest region to detect signs of acute aortic syndrome, including aortic dissection and intramural hematoma. It helps radiologists prioritize and triage cases by flagging suspicious studies, enabling faster diagnosis and improved workflow efficiency, although it is not a substitute for clinical decision-making.

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

CINA-iPE is an AI-powered software that analyzes contrast-enhanced CT scans (not dedicated CTPA) to help detect incidental pulmonary embolisms. It flags suspected positive cases in real-time to assist radiologists in prioritizing patients and improving workflow efficiency. It operates alongside standard care without altering original images and provides informative preview notifications but does not replace diagnostic review.

OTS Hip is a surgical system designed to assist orthopedic surgeons in planning and performing total hip arthroplasty (hip joint replacement) surgeries. It uses CT images of the patient's hip anatomy to create a detailed 3D model, enabling precise preoperative planning and real-time intraoperative navigation. This image-guided system improves surgical accuracy and helps position compatible hip prostheses according to the pre-planned locations, enhancing patient outcomes.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound machines designed for diagnostic imaging and fluid flow analysis of the human body. They include a new AI-powered Smart Doppler View ID feature that automatically navigates and selects the appropriate Doppler measurement groups on the touchscreen interface, enhancing clinician workflow and reducing manual navigation during cardiac ultrasound exams. This helps clinicians focus on key Doppler measurements efficiently during cardiac assessments.

Radify Triage is an AI-powered software that analyzes adult chest X-ray images to detect critical findings like pleural effusion and pneumothorax. It provides a notification within the PACS system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. It acts as a triage tool to flag suspicious cases but does not replace clinical decision-making.

Brainomix 360 Triage Stroke is an AI-powered radiological software that analyzes non-contrast head CT scans to detect suspected large vessel occlusions and intracranial hemorrhages. It helps clinicians by prioritizing and notifying cases that require urgent attention, improving workflow efficiency in the acute stroke setting. The device presents notifications through a web interface or mobile app, but is not intended for primary diagnosis and should be used alongside standard clinical assessments.

BraveCX is an AI-based software that analyzes adult chest X-ray images to detect pleural effusion and pneumothorax. It helps radiologists prioritize cases with suspected critical findings by flagging suspicious images in the PACS worklist, enhancing workflow efficiency without providing direct diagnostic decisions.