FDA Radiology AI Devices

The SKR 3000 is a digital radiography device by Konica Minolta designed to produce high-quality X-ray images of the human body for general-purpose diagnostic procedures. It replaces traditional film-based systems and includes features like advanced image processing and wireless connectivity. Its added indication includes pediatric imaging, helping clinicians accurately diagnose patients of all ages.

Second Opinion® CS is a computer-aided detection software designed to help dental health professionals detect and segment caries in radiographs of permanent teeth. Using AI and machine learning, it highlights potential caries lesions and provides detailed analysis on their overlap with tooth structures, improving diagnostic accuracy and assisting clinicians in reviewing dental images.

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.

AudaxCeph Cephalogram Analysis Software is a specialized software intended for dental professionals to assist in treatment planning by analyzing 2D cephalogram images. It automatically detects landmarks on images, allows measurement and superimposition, and supports orthodontic treatment planning. The software can be used as a desktop application or via the cloud, helping clinicians make informed decisions by digitizing and analyzing dental radiological images efficiently.

The Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.

CoLumboX is a software tool that helps healthcare professionals analyze lumbar spine x-ray images by automatically segmenting and measuring spine features. It provides quantitative information and highlights out-of-range measurements to assist in clinical evaluations, supporting more efficient and accurate patient assessments without making diagnoses itself.

Smile Dx® is an AI-powered software that assists dentists by analyzing dental X-ray images to detect issues like cavities, periapical radiolucencies, restorations, and measures bone levels. It supports digital and phosphor sensors, enhancing diagnosis and treatment planning by highlighting suspected dental findings for review, but it does not replace a dentist's judgment.

Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.

The !M1 mobile X-ray system by Solutions for tomorrow AB is a diagnostic mobile X-ray system designed to perform general radiography exams on pediatric and adult patients in healthcare facilities. It utilizes digital radiography technology with flat-panel detectors, offering configurations with detectors from manufacturers like Canon, Konica Minolta, and Vieworks, improving image quality and system performance. This helps clinicians obtain diagnostic images efficiently both inside and outside standard X-ray rooms, improving patient care.

Second Opinion® Pediatric is an AI-driven software designed to assist dental clinicians in detecting caries in bitewing and periapical radiographs of patients aged 4 years and older. It uses machine learning to identify and visually overlay potential caries lesions on dental X-rays, helping clinicians with improved detection accuracy without replacing professional judgment.