FDA Radiology AI Devices

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.

Viz ANEURYSM is an AI-powered software that analyzes CT angiogram images of the head to detect suspected aneurysms of at least 4mm. It helps radiologists prioritize patient studies by flagging and highlighting cases with suspected aneurysms in a standalone application. This assists in faster triage and review, improving workflow efficiency while ensuring diagnostic decisions remain with the radiologist.

Rapid is a medical image processing software that helps clinicians visualize and analyze tissue changes in CT and MRI images, particularly aiding in the selection of acute stroke patients for treatment. It uses AI/ML components to detect image artifacts and supports advanced imaging features such as perfusion, diffusion and dynamic contrast analysis.

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.

The Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.

Follicle Clarity is a cloud-based AI software that helps clinicians by automatically detecting and measuring the number and size of ovarian follicles from transvaginal ultrasound images. It provides graphical and tabular summaries of these measurements to assist in fertility monitoring and related clinical decisions.

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.

TOMTEC-ARENA is medical software designed to help clinicians review and quantify cardiovascular, fetal, and abdominal ultrasound images. It incorporates AI to provide semi-automated measurements, improving workflow efficiency while allowing users to edit or accept these measurements. This supports physicians in diagnosing suspected diseases by providing detailed and accurate imaging analysis.

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.