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 1639 FDA devices.

Sim&Size is a software tool that helps clinicians visualize blood vessels and devices inside them, aiding in planning and treatment of neurovascular conditions. It supports doctors by providing clear images of vascular anatomy to improve patient care.

FDA #
K253122
Product Code
PZO

AIR Recon DL is an MRI system designed to capture detailed images of the body using nuclear magnetic resonance technology. It helps clinicians by providing high-quality images that support diagnosis and treatment planning in radiology.

FDA #
K252379
Product Code
LNH

The Diagnostic Ultrasound System by Edan Instruments, Inc. is a device that produces medical ultrasound images to help clinicians visualize internal body structures and support diagnostic decisions. It assists healthcare providers by providing clear ultrasound images that improve patient assessment and care.

FDA #
K251268
Product Code
N/A

PeekMed web is an automated software tool designed to process radiological images, helping clinicians analyze medical images more efficiently and accurately.

FDA #
K252856
Product Code
QIH

The MC2 Portable X-ray System by Oxos Medical is a mobile imaging device used to capture X-ray images at the point of care. It enables clinicians to perform fluoroscopic X-ray imaging in a versatile and convenient format, helping to quickly diagnose and treat patients without moving them to a fixed imaging suite.

FDA #
K252068
Product Code
OWB

The Lumify Diagnostic Ultrasound System is a portable ultrasound device designed to assist clinicians by providing real-time ultrasound imaging to improve diagnostic capabilities in various medical settings.

FDA #
K252557
Product Code
IYN

The MAGNETOM series by Siemens Healthcare comprises advanced MRI systems used for diagnostic imaging. These devices help clinicians obtain detailed images of the body's internal structures, which can be enhanced or analyzed by AI tools to improve diagnosis and patient care.

FDA #
K252838
Product Code
LNH

The LIA Console is an imaging system employing Optical Coherence Tomography technology. It helps clinicians by providing detailed, high-resolution images of tissue structures, aiding in diagnosis and assessment in relevant surgical or clinical contexts.

Alzevita is an automated software designed to process radiological images, helping clinicians by enhancing image interpretation and diagnostic workflows.

FDA #
K252670
Product Code
QIH

AI-CVD is an automated software product designed to analyze radiological images to assist clinicians in processing and interpreting cardiovascular-related imaging data efficiently.

FDA #
K252029
Product Code
QIH
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