FDA Radiology AI Devices

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an AI-powered software that automatically measures the cardiothoracic ratio from chest X-ray images in the posterior-anterior view. It helps physicians by automatically calculating a key heart size measurement, supporting clinical assessments in hospitals and clinics for adult patients.

BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.

ClearRead Xray Pneumothorax is an AI-powered software tool designed to analyze adult chest X-rays and identify signs of pneumothorax larger than 5 mm. It functions as a triage system that notifies radiologists about suspected urgent cases, helping prioritize the review workflow but not replacing diagnostic interpretation.

Second Opinion is an AI-based software designed to assist dental professionals by automatically detecting and highlighting potential dental issues, such as caries and restorations, on bitewing and periapical radiographs. It acts as a second reader, improving diagnostic accuracy and helping clinicians identify abnormalities more effectively.

BoneView by Gleamer is an AI-powered software that analyzes X-ray images of bones to detect and highlight fractures. It acts as a concurrent reading aid for clinicians, improving the accuracy and confidence of fracture diagnosis from radiographs across a wide range of anatomical areas. By providing clear visual annotations, it helps reduce missed fractures and supports better patient care.

Annalise Enterprise CXR Triage Pneumothorax is a software tool that uses artificial intelligence to analyze adult chest x-rays for signs of pneumothorax and tension pneumothorax. It assists trained clinicians by automatically prioritizing and triaging cases in their worklist, enabling faster attention to urgent findings. The device integrates with hospital imaging systems and helps optimize workflow without replacing clinical judgment.

The Micro C Medical Imaging System, M01 by OXOS Medical, Inc. is a handheld, portable mobile X-ray device intended for use by trained clinicians to capture diagnostic images of extremities. It features an AI-based software called AiLARA that recommends power settings and exposure times to optimize image quality and reduce retakes, enhancing clinician efficiency and patient safety.

Eclipse II with Smart Noise Cancellation is a software module integrated within the Carestream ImageView application that enhances digital radiography images by reducing noise using a Convolutional Neural Network. It supports various Carestream digital radiography detectors. This technology allows for up to 50% dose reduction in certain detector types without sacrificing image quality, helping clinicians obtain clearer x-ray images at lower radiation doses, thus improving patient safety and diagnostic confidence.

qXR-BT by Qure.ai Technologies is an AI-powered software designed to analyze chest X-ray images to help physicians confirm the position of breathing tubes. It generates secondary digital images with highlighted tube tips and anatomical landmarks, providing valuable adjunctive information during radiological assessment.

HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.