FDA Radiology AI Devices

AVIEW CAC is a software that analyzes non-contrast chest CT scans to quantify calcified plaques in coronary arteries, calculate the Agatston score, and provide risk stratification based on calcium scoring, age, and gender. It helps radiologists and cardiologists by supporting image storage, transfer, and display, facilitating clinical decision-making for coronary artery disease risk assessment.

The Voluson Signature 20 and Voluson Signature 18 are advanced diagnostic ultrasound systems designed primarily for general radiology and specialized OB/GYN use. They provide high-performance ultrasound imaging, including real-time 3D/4D acquisition and various Doppler imaging modes, to help clinicians visualize and analyze the human body and fluids. These systems support multiple clinical applications such as fetal imaging, abdominal, cardiac, vascular, musculoskeletal, and more, aiding in diagnosis and patient care in hospital or clinical settings.

Overjet Caries Assist-Pediatric is an AI-powered software designed to assist dentists by automatically detecting and outlining dental caries in bitewing and periapical radiographs of pediatric patients aged 4-11. It provides additional visual cues to support clinical diagnosis but is not a replacement for the dentist's comprehensive review and judgment.

CT Cardiomegaly is a command-line software tool designed to automatically measure the cardiothoracic ratio from CT chest images. It uses machine learning algorithms to segment the heart and thoracic cavity and calculate both linear and area-based cardiothoracic ratios. This assists physicians in identifying cardiomegaly, providing quantitative measurements to support clinical decisions within healthcare settings.

Overjet Charting Assist is an AI-powered medical image processing system that helps dental professionals detect and identify dental structures such as teeth anatomy and past restorative treatments on various dental radiographs. It assists in creating dental charts more efficiently by analyzing bitewing, periapical, and panoramic images, helping reduce manual charting efforts by over 80%.

CEPHX is a software tool designed for orthodontists that uses AI to analyze cephalometric x-ray images. It automatically identifies important anatomical landmarks on 2D x-rays, aiding in diagnosis, treatment planning, and patient consultation for individuals over 14 years old. This helps clinicians effectively monitor and simulate orthodontic treatment progress.

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

DASI Dimensions (V1.0) is a clinical decision support software that processes multiphase CTA chest images to generate automated measurements of cardiovascular structures. It helps cardiologists and radiologists by providing detailed images and numerical data to support planning for aortic valve replacement procedures, improving accuracy and efficiency of pre-operative assessments.

VEA Align is a cloud-based software developed by EOS imaging that uses 2D X-ray images acquired from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It applies machine learning algorithms to automatically place anatomical landmarks on images, helping clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. It supports both pediatric and adult patients and enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.

qXR-LN is an AI-based software device that analyzes frontal chest X-rays to detect and mark suspected lung nodules between 6 and 30 mm. It acts as a second reader to assist physicians like radiologists and pulmonologists, providing adjunctive information to improve detection accuracy without substituting the original image or clinical judgment.