FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

FDA #
K240712
Product Code

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

FDA #
K241719
Product Code

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.

FDA #
K242709
Product Code

The Caduceus S is an augmented reality-based navigation system designed to assist surgeons in accurately placing pedicle screws during percutaneous spine surgery. It leverages intraoperative CT or 2D/3D C-arm imaging and optical tracking, projecting navigation data directly into a headset worn by the surgeon to improve precision and visualization during procedures involving the thoracic and lumbosacral spine.

FDA #
K242271
Product Code

The Riptide Aspiration System is a medical device designed to restore blood flow in patients suffering from acute ischemic stroke caused by intracranial large vessel occlusions. It uses continuous aspiration via specialized catheters and pumping system to remove blood clots from critical arteries in the brain, helping clinicians quickly reopen blocked vessels and potentially improve patient outcomes.

FDA #
K243080
Product Code

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

FDA #
K242215
Product Code

nordicMEDiVA is an advanced software platform designed to analyze and visualize functional and dynamic MRI data of the brain. It automates image processing pipelines and provides clinicians with derived imaging parameters through a web-browser interface, facilitating the evaluation of brain function and structure to aid clinical decision-making.

FDA #
K243209
Product Code

The REMI-AI Rapid Detection Module (REMI-AI RDM) is an AI-based seizure detection software integrated into the REMI Remote EEG Monitoring System. It analyzes EEG data in near real-time to notify clinicians of potential electrographic seizures, aiding in patient evaluation by marking events in the EEG record. It is intended for use in non-ICU healthcare settings with adult and pediatric patients (6+ years).

FDA #
K240408
Product Code

SIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.

FDA #
K241242
Product Code

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.

FDA #
K242556
Product Code
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