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.

DentalMonitoring is a medical software device that uses AI to analyze pictures of a patient's mouth taken via smartphone and proprietary hardware. It helps dental professionals remotely monitor orthodontic treatments by assessing oral hygiene, soft tissue, dental conditions, alignment, and occlusion. It provides 2D and 3D monitoring capabilities to track treatment progress safely and non-invasively.

Product Code
SBC
Panel
Dental

RAYDENT SW is software that helps dental professionals plan treatments and design orthodontic and prosthetic devices by using 3D imaging data and simulations. It assists in creating treatment plans and designing devices such as clear aligners, crowns, veneers, and bridges, improving precision and efficiency in dental care.

FDA #
K233625
Product Code
PNN
Panel
Dental

The X-Guide Surgical Navigation System is an advanced computer-assisted navigation tool designed to assist dental surgeons during preoperative planning and intraoperative guidance of dental implants and endodontic access procedures. It integrates machine learning software to automatically process CT and intraoral scan images to segment anatomical structures and enhance surgical precision, improving patient safety and surgical outcomes.

FDA #
K232148
Product Code
QRY
Panel
Dental
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