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.

The Lung Vision System is a medical imaging tool designed to assist clinicians by processing radiological images of the lungs. It helps improve visualization and analysis, aiding in the detection and diagnosis of lung-related conditions.

FDA #
K183593
Product Code
LLZ

AI Rad Companion (Engine) by Siemens Medical Solutions is a software platform designed to assist technicians and physicians in viewing, processing, and analyzing medical images from multiple modalities. It supports integration with PACS systems and allows external AI-based post-processing extensions, improving clinical image analysis and workflow.

FDA #
K183272
Product Code
LLZ

The SIGNA Premier is a whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution and high signal-to-noise ratio images in short scan times. It supports imaging of multiple body regions including the head, spine, breast, heart, abdomen, and musculoskeletal system, and uses advanced software featuring deep learning algorithms to automate steps in brain MRI examinations, thereby helping clinicians improve workflow and diagnostic consistency.

FDA #
K183231
Product Code
LNH

Centricity Universal Viewer by GE Healthcare is a medical imaging software solution designed to display, manage, analyze, and share medical images from multiple imaging modalities. It facilitates radiologists and cardiologists in interpreting diagnostic images, improving workflow and clinical decision-making. It supports many imaging formats but is not intended for digital pathology diagnosis. The product enhances clinicians' ability to view and interpret images efficiently across healthcare systems.

FDA #
K182419
Product Code
LLZ

SubtlePET is a software product that uses deep neural network-based AI algorithms to reduce noise and enhance the structural quality of PET images, including PET/CT and PET/MRI scans. It integrates into existing clinical workflows by acting as a DICOM node to process and forward enhanced images, helping radiologists and nuclear medicine physicians better visualize and analyze PET scans for improved diagnostic confidence.

FDA #
K182336
Product Code
KPS

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also support other applications such as fetal, abdominal, pediatric, vascular, and musculoskeletal imaging. These systems use ultrasound technology to produce detailed real-time images, including 3D and 4D imaging, helping clinicians diagnose and monitor various conditions effectively. The devices also feature enhanced workflow tools, advanced imaging options, and support comprehensive networking and data sharing capabilities, improving the efficiency and accuracy of ultrasound examinations.

FDA #
K181685
Product Code
IYN

Ziostation2 is an advanced medical image processing software that supports multiple imaging modalities including CT, MRI, Ultrasound, and X-ray. It helps clinicians view and analyze medical images by providing tools for image quantification, manipulation, and communication. This software is designed to enhance the workflow and diagnostic process for radiologists and other trained medical professionals.

FDA #
K181892
Product Code
LLZ

The Clarius Ultrasound Scanner is a portable, wireless ultrasound imaging system designed for diagnostic use across multiple body regions. It connects via Wi-Fi to mobile devices, allowing healthcare professionals to visualize real-time, high-resolution ultrasound images and fluid flow analysis in diverse clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more. This device facilitates medical imaging in varied clinical environments by enabling image acquisition on tablets and smartphones.

FDA #
K180799
Product Code
IYN

Venue is a general-purpose diagnostic ultrasound system designed for use by qualified healthcare professionals in various clinical settings including critical care, emergency rooms, and outpatient offices. It supports multiple ultrasound imaging applications for different body regions, facilitating imaging, measurement, and analysis of human body structures and fluid, thereby aiding clinical diagnosis and interventional procedures.

FDA #
K180599
Product Code
IYN

The DR 800 with MUSICA Dynamic by Agfa HealthCare is an advanced fluoroscopic X-ray system designed for dynamic imaging of various body parts, such as gastrointestinal and urogenital tract examinations and angiography. It replaces traditional image intensifier technology with flat-panel digital detectors and incorporates MUSICA Dynamic software for enhanced image processing, improving image quality and aiding clinicians in accurate diagnosis while supporting pediatric and adult imaging needs.

FDA #
K180589
Product Code
JAA
Page 12 of 14134 results

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.