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.

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 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.

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.

Limbus Contour is a software tool designed to help medical professionals automatically create accurate contours of healthy anatomical structures from CT and MRI images. These contours are used to plan and evaluate radiation treatment for cancer patients, improving efficiency and consistency in treatment preparation.

The SpineUs™ System by Verdure Imaging is a diagnostic ultrasound platform designed to help trained chiropractors and radiologists acquire, view, segment, and measure spinal ultrasound images. It uses AI technology to automatically segment vertebral bone structures and provides 3D reconstructions and quantitative measurements such as intervertebral angles and spine curvature, aiding clinical evaluation of the spine in both hospital and clinic settings.

LVivo Software Application is an AI-powered software platform designed to automatically analyze ultrasound images of the heart and bladder. It calculates important functional and structural parameters of the heart's left and right ventricles and the bladder volume, helping clinicians with rapid and accurate assessments during routine echocardiographic exams and point-of-care settings.

MuscleView is an AI-powered software that automatically segments muscles and bones in MRI scans of the lower limbs. It calculates useful metrics such as muscle and bone volume, fat infiltration, and asymmetry to assist physicians in analyzing musculoskeletal health. The segmentations need to be reviewed and edited by trained clinicians. This tool helps improve the efficiency and accuracy of muscle and bone analysis from MRI images but is not intended for diagnostic use of diseases.

The CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It aids physicians by providing calcium segmentation and quantification information integrated into their workflow, helping assess coronary artery health.

Sourcerer is a software tool designed for neurologists and EEG technologists to visualize brain activity by integrating EEG data with MRI images. It helps localize sources of brain activity by projecting EEG signals onto an idealized head model, aiding in clinical diagnoses such as epilepsy evaluation.