FDA Radiology AI Devices

cvi42 Software Application is a medical imaging software developed by Circle Cardiovascular Imaging Inc. that supports clinicians by enabling viewing, post-processing, and quantitative analysis of cardiovascular magnetic resonance (MR) and computed tomography (CT) images. It uses semi-automated machine learning algorithms to assist in measuring cardiac function, vessel characteristics, and calcified plaques, helping medical professionals in diagnostic decision-making related to heart and adjacent vessels.

VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.

The HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a versatile ultrasound imaging system used by healthcare professionals to obtain and analyze ultrasound images and body fluids. It offers multiple imaging modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, and advanced AI-based features such as BiometryAssist, HeartAssist, ViewAssist, and others to aid in image recognition, measurement, and workflow efficiency. It is intended for clinical use in various applications including fetal, abdominal, cardiac, musculoskeletal, and more.

The Intra-Operative Positioning System (IOPS) by Centerline Biomedical uses a fiducial tracking pad and a guidewire handle for real-time tip positioning and navigation during endovascular interventions. By leveraging 3D vascular models derived from prior CT scans, it helps clinicians accurately guide catheters and guidewires inside the descending aorta as an adjunct to fluoroscopy, enhancing procedure precision without providing a diagnosis itself.

The SPECTRALIS with Flex Module is an advanced eye imaging device designed for non-contact visualization of the posterior segment and vasculature of the retina and choroid in adults and pediatric patients, including those in supine (lying down) position. It helps ophthalmologists detect and monitor various eye conditions by providing high-quality images of eye structures, enabling improved diagnosis and management.

The syngo Application Software is a medical imaging software developed by Siemens that enables real-time viewing, manipulation, 3D visualization, communication, and postprocessing of medical images. It supports diagnostic review and image-guided interventional procedures across multiple imaging modalities and clinical applications, improving workflow and aiding clinicians in diagnosis and treatment planning.

X Sensor is a digital intraoral dental x-ray sensor that captures x-ray photons and instantly converts them to digital images for dentists to view and analyze. It enhances dental diagnostic workflows by providing faster image acquisition with high resolution and image quality, making diagnosis more efficient and reliable.

AutoChamber is an AI-powered software tool designed to analyze both non-contrast and contrast-enhanced chest CT scans to automatically measure and report volumes of cardiac chambers including left atrium, left ventricle, right atrium, right ventricle, and left ventricular wall. It assists healthcare providers by providing quantitative imaging data that helps identify conditions such as enlarged heart and left ventricular hypertrophy, thus aiding in further clinical evaluation and management of cardiovascular risk.

The Blueprint Patient-Specific Instrumentation system by Stryker Corporation includes hardware and software components designed to assist surgeons in planning and performing shoulder replacement surgeries, specifically reversed shoulder arthroplasty. It uses CT scans to generate patient-specific surgical guides and implants, improving the precision of implant placement and potentially leading to better surgical outcomes for patients with shoulder joint conditions.

EchoMeasure by iCardio.ai is an AI-powered software that analyzes previously acquired cardiac ultrasound images to automatically measure key cardiac anatomical parameters. It assists cardiologists and healthcare professionals by providing accurate measurements for clinical decision-making, enhancing efficiency and supporting diagnostic review.