FDA Radiology AI Devices

BoneMRI v1.4 is an image processing software that analyzes 3D gradient echo MRI scans to enhance visualization of bone structures in the pelvic and lumbar spine regions. It uses a convolutional neural network algorithm to generate images with improved bone contrast compared to surrounding soft tissue, helping clinicians better assess bone morphology and density without the need for CT scans. It is intended for use by radiologists and orthopedic surgeons to aid in image interpretation, but not for tumor diagnosis.

Syngo Dynamics (Version VA40F) is a software medical device from Siemens designed to assist healthcare professionals in reviewing and analyzing medical images for disease detection and patient management. It supports multiple imaging modalities including ultrasound, x-ray angiography, CT, MR, nuclear medicine, and others, with applications primarily focused on cardiology, vascular, and fetal imaging. The software offers advanced image processing tools and semi-automated measurement capabilities such as left ventricular ejection fraction estimation, helping clinicians interpret complex imaging data efficiently within healthcare networks.

Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to measure and assess spinal parameters, such as alignment, stability, and motion. It helps healthcare professionals by providing quantitative metrics and visualizations, improving clinical decision-making regarding spinal health and treatments.

QIR Suite is a software tool designed to help medical professionals analyze cardiovascular magnetic resonance images. It uses standard and deep learning algorithms to automate measurements like heart chamber function and blood flow, aiding diagnosis and treatment planning for adult patients with heart conditions.

NS-HGlio is a software tool that assists clinicians in analyzing MRI images of patients with high-grade brain gliomas by automatically labeling and measuring tumor regions. It supports doctors by providing volumetric data and visual overlays to help monitor tumor progression or treatment response, but it is not intended for primary diagnosis.

Viz RV/LV is a software tool that uses artificial intelligence to automatically measure the size of the right and left ventricles of the heart from CT pulmonary angiogram scans. It provides annotated images and a summary report to assist clinicians in evaluating right ventricular enlargement, potentially aiding diagnosis and treatment decisions.

MI View&GO is a software application developed by Siemens for medical professionals to review, manipulate, and analyze medical images from modalities like PET, SPECT, CT, and MRI. It integrates molecular imaging with anatomical data to support disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy planning. The software enhances image processing efficiency directly at the scanner console, allowing for timely quality assessment and basic reading of images.

ClearPoint Maestro Brain Model is a software tool that uses AI to automatically identify, label, and measure the volume and shape of various brain structures from MRI scans. This helps clinicians by simplifying and speeding up the process of brain image analysis, supporting diagnosis and treatment planning in neurological conditions.

Customize is a prescription-use software tool designed to assist clinicians in planning ankle arthroplasty surgeries. It uses CT and X-ray images to generate 3D models and helps visualize and modify surgical treatment plans. The software incorporates AI to segment anatomical structures, improving preoperative planning and communication of treatment options.

cvi42 Auto Imaging Software Application is an AI-powered medical imaging software designed to assist clinicians in evaluating cardiovascular MR and CT images. It uses machine learning to semi-automatically contour cardiac structures, perform calcium scoring, and analyze coronary arteries, aiding in diagnosis and quantitative assessment of heart and vessel conditions.