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 1673 FDA devices.

BIOGRAPH One by Siemens Healthineers AG is an advanced tomographic imaging device that integrates emission computed tomography and nuclear magnetic resonance technologies. It helps clinicians by providing detailed images that combine functional and anatomical information, facilitating accurate diagnosis and patient management.

FDA #
K253023
Product Code
OUO

The Orthoscan TAU MVP Mini C-Arm System is a mobile fluoroscopic X-ray device that provides real-time imaging to assist clinicians during medical procedures, enabling better visualization of anatomy for accurate treatment and improved patient care.

FDA #
K252579
Product Code
OXO

The VERITON CT 300 and 400 Series Digital SPECT/CT Systems combine CT and SPECT imaging to provide detailed anatomical and functional images. This helps clinicians better diagnose and manage diseases by combining structural and metabolic information in one device. It supports improved patient care through enhanced imaging capabilities.

FDA #
K254001
Product Code
KPS

View by GE Healthcare is an image processing system for radiology that helps clinicians by enhancing and managing medical images to support diagnosis and patient care.

FDA #
K253639
Product Code
LLZ

3DICOM MD Cloud is an image processing system used in radiology that helps clinicians to view and analyze medical images in a cloud-based environment, enhancing accessibility and interpretation of imaging studies.

FDA #
K253784
Product Code
LLZ

LOGIQ Totus is an ultrasound imaging system that uses pulsed Doppler technology to help clinicians visualize blood flow and tissue structures in real time. It assists in diagnosing various conditions by providing high-quality ultrasound images, supporting better patient care and clinical decision-making.

FDA #
K253370
Product Code
IYN

The DS Core Detect by Dentsply Sirona, Inc. is a medical imaging analyzer designed to assist clinicians by analyzing medical images to improve diagnostic processes. It utilizes AI technology to detect or evaluate medical conditions from radiological images, aiding healthcare professionals in efficient and accurate patient assessment.

FDA #
K253009
Product Code
MYN

The LOGIQ Fortis is an ultrasound imaging system that uses pulsed Doppler technology to help clinicians visualize and assess blood flow and other body structures in real time. It assists in diagnostic evaluations by providing detailed ultrasonic images, facilitating better patient care through improved imaging.

FDA #
K253366
Product Code
IYN

BriefCase-Triage: CARE Multi-triage CT Body is an AI-powered software that analyzes CT images of the body to assist clinicians by prioritizing urgent cases, thereby improving workflow and patient care in radiology departments.

FDA #
K252970
Product Code
QAS

maiLink by Maihub Corp. is an AI-based radiological image processing system that assists radiologists by enhancing and analyzing medical images to improve diagnostic accuracy and workflow efficiency.

FDA #
K253008
Product Code
LLZ
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