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.

uOmniscan is a software that enables real-time remote collaboration and control of medical imaging devices, especially MRI scanners. It helps healthcare professionals remotely manage scans, train technicians, and enhance communication across different locations, increasing workflow efficiency and access to expert guidance.

FDA #
K243666
Product Code
LLZ

rTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.

FDA #
K243333
Product Code
LLZ

CT Collaboration Live is a software application integrated into Philips CT systems that enables real-time remote communication for consultation, training, and support via chat, audio/video calls, screen sharing, and remote control. It facilitates collaboration between CT system operators and remote clinical users but is not intended for remote diagnostic image review.

FDA #
K242329
Product Code
LLZ

The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.

FDA #
K212005
Product Code
LLZ
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