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.
Tip: combine filters with the search box to narrow down devices.

Showing 207 FDA devices matching your filters.

ProKnow DS is an image processing system designed to assist clinicians by managing, analyzing, and improving the workflow of radiological image data. It helps healthcare professionals efficiently handle medical images to enhance patient care.

FDA #
K251363
Product Code
LLZ

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

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

AI-Rad Companion Prostate MR is a software tool designed to assist radiologists by processing prostate MR images using artificial intelligence, helping improve detection and diagnosis of prostate-related conditions.

FDA #
K252608
Product Code
LLZ

Image Suite by Carestream Health Inc. is a radiological image processing system designed to assist clinicians in managing and analyzing medical images, enhancing diagnostic workflows.

FDA #
K251168
Product Code
LLZ

SurgiTwin is a radiological image processing system designed to assist clinicians by enhancing or analyzing medical images to support diagnostic and surgical decision-making processes.

FDA #
K250290
Product Code
LLZ

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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