FDA Radiology AI Devices

The EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is software that assists medical professionals by automatically analyzing chest X-ray images to detect misplaced endotracheal tubes. It uses deep learning to flag suspicious cases and prioritize them in the workflow, helping radiologists review these urgent cases more quickly. The software provides alerts when the tube tip is positioned too high, too low, or incorrectly and supports clinical decision-making by improving triage efficiency.

BriefCase-Triage is an AI-based radiological software designed to assist clinicians by automatically analyzing contrast-enhanced CT images including the lungs to detect suspected cases of incidental pulmonary embolism. It notifies users with preview images for triage and prioritization, enabling faster attention to critical cases without replacing standard diagnostic workflows.

rTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.

The INTRABEAM (700) system by Carl Zeiss Meditec AG is a mobile radiation therapy device designed to deliver targeted low-energy X-ray radiation during intraoperative, intracavity, interstitial, and contact radiotherapy treatments of tumors or tumor beds. It includes accessories such as a SMART Stand, spherical applicators for precise radiation delivery, and a sizer set to assist in applicator selection. The system aids clinicians by providing controlled radiation doses directly at the tumor site during surgery, potentially improving cancer treatment efficacy while sparing surrounding healthy tissue.

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.

BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.

The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.

CT Collaboration Live is a software application integrated into Philips CT systems that enables real-time remote communication for consultation, training, and support via chat, audio/video calls, screen sharing, and remote control. It facilitates collaboration between CT system operators and remote clinical users but is not intended for remote diagnostic image review.

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-based software tool that analyzes adult chest X-rays to detect critical conditions such as pleural effusion and pneumothorax. It prioritizes cases in the clinical workflow by providing passive notifications in the radiologist's PACS or workstation, helping healthcare professionals manage urgent cases efficiently. The software supports DICOM and common image formats and is intended to assist rather than replace clinical decision-making.

BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.