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.

Showing 273 FDA devices matching your filters.

The Alphenix INFX-8000V is an interventional fluoroscopic X-ray system designed by Canon Medical Systems Corporation. It provides real-time X-ray imaging to assist clinicians during interventional procedures, allowing enhanced visualization of anatomy and devices, thereby improving procedure accuracy and patient care.

FDA #
K251602
Product Code
OWB

HPACS is an image processing system designed for radiology that helps clinicians by enhancing and managing medical images, potentially improving diagnosis and workflow efficiency.

FDA #
K250039
Product Code
LLZ

Philips IntelliSpace Cardiovascular is a medical image processing system designed to assist clinicians in analyzing cardiovascular images. It facilitates improved visualization and assessment of heart-related conditions to support patient diagnosis and treatment planning.

FDA #
K251215
Product Code
LLZ

The uWS-Angio Pro is an image processing system developed by Shanghai United Imaging Healthcare Co., Ltd. It is used in radiology to assist clinicians by processing medical images, potentially improving the visualization and analysis of angiographic studies.

FDA #
K250045
Product Code
LLZ

Axial3D Insight is a software that automatically processes radiological images to help clinicians analyze complex anatomical structures. It aims to enhance medical imaging interpretation and assist in treatment planning.

FDA #
K250369
Product Code
QIH

The uWS-Angio is an image processing system used in radiology to assist clinicians by enhancing and analyzing medical images, improving diagnosis and patient care.

FDA #
K250040
Product Code
LLZ

The Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-2) is a radiological image processing system designed to assist clinicians during minimally invasive prostate surgery by providing enhanced navigation through medical imaging, improving surgical precision and outcomes.

FDA #
K242314
Product Code
LLZ

CT:VQ by 4DMedical Limited is a medical imaging system that uses computed tomography (CT) technology to help clinicians visualize and assess the lungs and ventilation. It supports diagnosis and treatment planning by providing detailed ventilation imaging and analysis based on CT scans.

FDA #
K251484
Product Code
JAK

VistaSoft 4.0 and VisionX 4.0 are automated software tools designed to assist clinicians by processing radiological images. They help improve image interpretation to support diagnostic decisions in medical imaging.

FDA #
K250947
Product Code
QIH

Rapid DeltaFuse by iSchemaView Inc. is an image processing system designed for radiological applications. It helps clinicians by efficiently processing and analyzing medical images to support diagnostic decisions.

FDA #
K252526
Product Code
LLZ
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