FDA Radiology AI Devices

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.

The eMotus Respiratory Motion Management System by EmpNia Inc. helps monitor and record patients' breathing patterns to improve the accuracy of CT diagnostic imaging and radiation therapy. By tracking respiratory motion, it aids clinicians in synchronizing image acquisition and radiation delivery, reducing motion-related artifacts and improving treatment precision. The device uses optical fiber sensors attached to the patient's chest or abdomen to generate a respiratory waveform and gate signals that help coordinate imaging and therapy devices.

The Philips iCT CT System is a computed tomography scanner designed for diagnostic imaging of the head, body, cardiac, and vascular regions. It produces detailed cross-sectional images by reconstructing X-ray data taken from multiple angles, aiding clinicians in diagnosing a range of conditions. The system offers updated hardware and software improvements for enhanced image quality, cybersecurity, and usability without altering its core imaging capabilities.

The CT Scanner TSX-501R/1 V11.1 by Canon Medical Systems Corporation is an advanced computed tomography system that uses a photon counting detector to capture high-quality cross-sectional volume images of the whole body. This system helps clinicians perform specialized studies by providing detailed imaging data to support diagnosis and treatment planning for adult patients.

The TMINI Miniature Robotic System is a robotic surgical tool designed to assist orthopedic surgeons in accurately placing knee implant components during total knee replacement surgery. It uses preoperative CT scans to generate 3D models for surgical planning and utilizes robotic guidance during surgery to ensure precise bone preparation and implant placement, improving surgical accuracy and patient outcomes.

CardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.

Methinks NCCT Stroke is an AI-based software designed to assist clinicians by automatically analyzing non-contrast head CT scans to detect signs of intracranial hemorrhage and large vessel occlusion. It prioritizes and notifies suspected positive cases to improve workflow efficiency and triage in stroke care, offering rapid alerts that support clinical decision-making without replacing standard diagnostic procedures.

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

Viz Subdural+ is an AI-powered software that automatically analyzes head CT scans to measure subdural collections and midline shift. It helps clinicians by providing automated volume and width measurements of subdural collections, improving efficiency and accuracy in brain injury assessment.

The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.