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 TECHFIT DISRP® System is a digital surgery platform designed to help clinicians plan and simulate maxillofacial surgeries. It processes CT scan data to create 3D models and surgical guides or splints that assist surgeons during operations by translating imaging information into physical tools for improved surgical precision and patient-specific treatment.

FDA #
K242263
Product Code
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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