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 Dental CBCT X-ray System by Yian Medical Technology is a dental imaging device that produces 2D panoramic, cephalometric images, and 3D cone-beam CT images of the dental, oral, and maxillofacial region. It aids healthcare professionals in diagnosing adult and pediatric patients, providing detailed digital X-ray images for dental and oral care.

FDA #
K251642
Product Code
OAS

The Dental Cone Beam Computed Tomography System by Yofo Medical Technology Co., Ltd. is designed for dental and maxillofacial imaging using cone beam CT technology. It produces detailed 3D images of patients' oral and maxillofacial regions to assist clinicians in diagnosis and treatment planning, improving patient care in dental and maxillofacial medicine.

FDA #
K243337
Product Code
OAS

The RCT600 is a dental and maxillofacial imaging system that uses cone beam computed tomography (CBCT), panoramic, and cephalometric X-ray imaging to help dentists and healthcare professionals diagnose and plan treatment for both adult and pediatric patients. It produces high-quality 3D and 2D images of hard tissues like bones and teeth, as well as wrist images for orthodontic growth assessment, enabling better clinical decisions and patient care.

FDA #
K243903
Product Code
OAS

The Green X 12 SE (PHT-40CHS) is a 4-in-1 advanced digital X-ray system for dental imaging that combines panoramic, cephalometric, 3D Cone Beam CT (CBCT) and model scanning capabilities in one device. It helps dentists and healthcare professionals provide detailed diagnostic images of the head, neck, and dental structures, supporting accurate diagnosis and treatment planning for adult and pediatric patients, including orthodontics. This device enhances imaging workflow and diagnostic capabilities by integrating multiple imaging modalities with modern digital detectors and software.

FDA #
K243088
Product Code
OAS

Green X 21 (PHT-90CHO) is an advanced 6-in-1 digital dental X-ray system that combines multiple imaging modalities including panoramic, cephalometric, and 3D CT scans for diagnostic details of dento-maxillofacial, sinus, TMJ, and ENT regions. It helps clinicians by providing comprehensive imaging from one device to improve diagnosis and treatment planning, especially for adult and pediatric dental and ENT patients.

FDA #
K243081
Product Code
OAS

The Dental Cone-beam Computed Tomography (FinScan F350) is an imaging system designed for dental and maxillofacial diagnostic support. It uses cone-beam CT technology along with panoramic and cephalometric X-ray imaging to produce detailed images of the dento-maxillofacial and TMJ structures, aiding dentists and health professionals in diagnosis, including assessment of growth and maturity for orthodontic treatment.

FDA #
K242805
Product Code
OAS
Page 1 of 16 results
1

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.