FDA Radiology AI Devices

The ULTRA 1040 is a portable X-ray device designed for use by trained physicians or technicians to capture X-ray images of patients' extremities. It allows for flexible diagnostic imaging outside traditional settings, helping clinicians assess bone and joint conditions conveniently. It supports use with an X-ray detector and image processing software for image acquisition and processing.

The Wireless/Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited are digital imaging devices used with specialized software to capture and process X-ray images of all body parts for general radiographic applications. They convert X-rays into high-quality digital images, aiding radiologists in diagnosis by replacing traditional film-based systems.

The CLARUS 700 is an advanced ophthalmic imaging device designed to capture high-resolution images of the retina and ocular structures to aid clinicians in diagnosing and monitoring eye diseases. It supports true color, autofluorescence, fluorescein angiography, and indocyanine green angiography imaging modes over wide fields of view. The device incorporates AI algorithms for optic nerve head detection to improve image alignment and provides tools for image annotation and measurement, facilitating comprehensive eye health analysis.

The Dental Cone Beam Computed Tomography System by Yofo Medical Technology Co., Ltd. is designed for dental and maxillofacial imaging using cone beam CT technology. It produces detailed 3D images of patients' oral and maxillofacial regions to assist clinicians in diagnosis and treatment planning, improving patient care in dental and maxillofacial medicine.

The FLUOBEAM LX and FLUOBEAM LM are surgical imaging systems that use near infrared fluorescence to help surgeons visualize blood vessels, tissue perfusion, parathyroid glands, lymphatic vessels, and tissues that have absorbed specific dyes during surgery. By enhancing real-time images of tissues, these devices assist clinicians in making precise assessments during complex surgeries, improving patient outcomes.

RayCare (2024A SP1) is a software system designed to support cancer treatment by assisting clinicians with treatment planning, management, scheduling, and follow-up for radiation therapy and oncology care. It includes an image viewer for reviewing and annotating images related to patient positioning during treatment, aiding clinicians in delivering precise radiotherapy treatment.

VitalRhythm is a cloud-based AI software that continuously analyzes ECG signals to detect various cardiac arrhythmias. It works with a wearable biosensor (VitalPatch) and displays results to healthcare professionals for non-urgent clinical decision-making in outpatient and non-critical care settings. It helps clinicians monitor heart rhythms remotely and efficiently, assisting in diagnosis without replacing clinical judgment.

Clarius Prostate AI is an AI-powered ultrasound software tool integrated into the Clarius Ultrasound Scanner system. It assists qualified healthcare professionals by automatically detecting, segmenting, and measuring prostate volume in ultrasound images, helping to streamline clinical workflow and improve prostate assessment accuracy while allowing manual adjustments. It is intended for adult male patients and supports prostate imaging with curvilinear and endo-cavitary scanners.

LARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.

The Medyssey Navigation System is a reusable surgical instrument set designed to work with the Medtronic StealthStation navigation system. It helps surgeons precisely locate anatomical structures during spinal surgeries by integrating with imaging data such as CT or MR-based models, fluoroscopy images, or digitized landmarks. This improves accuracy in placing spinal fixation implants and supports open or minimally invasive procedures.