FDA Radiology AI Devices

syngo.via RT Image Suite is a software tool designed to assist clinicians in viewing, manipulating, and contouring 3D and 4D medical images from various modalities such as CT, PET, MRI, and CBCT. It helps prepare radiation therapy treatment plans by enabling visualization, semi-automatic and automatic contouring of tumors and organs, image registration, and image fusion. The software improves workflow efficiency and treatment accuracy in radiation oncology.

ART-Plan (v.2.2.0) is a medical software platform designed to help clinicians involved in radiotherapy for cancer patients. It allows users to contour regions of interest on 3D images, perform image registration and fusion from multiple imaging modalities (CT, MRI, CBCT), generate synthetic CT images using deep learning, and support decision-making for treatment replanning. This assists medical professionals in precisely targeting radiation therapy and adapting treatment based on daily patient imaging data, improving safety and treatment efficacy for cancer patients aged 18 and above.

Rapid by iSchemaView Inc. is a medical image processing software designed to help clinicians analyze CT and MRI images, including functional and dynamic datasets like CT Perfusion and diffusion-weighted MRI. It facilitates quick visualization, quantification, and interpretation of brain tissue changes often seen in acute stroke, helping physicians select patients for endovascular thrombectomy and assess cerebral hemodynamics. The software supports both standard and C-arm CT images and assists in managing complex imaging data efficiently, enhancing clinical workflow and patient care in neurological emergencies.

VisAble.IO is a software tool that helps physicians plan and evaluate liver ablation treatments by processing CT and MRI images. It assists in identifying treatment targets, planning needle placement virtually, and confirming the treatment area post-procedure to improve procedure accuracy and patient outcomes.

AI-Rad Companion Organs RT is an AI-powered medical imaging software designed to automatically segment organs from CT and MR scans to assist radiation therapy treatment planning. It uses deep learning algorithms to produce contours of organs-at-risk, which clinicians can review and edit before using them in treatment planning systems. This software saves time and improves the accuracy of radiation therapy preparation by providing automated organ delineation, intended for use by trained medical professionals.

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

ART-Plan is a radiotherapy treatment planning software that assists clinicians by visualizing and fusing multimodal medical images, automatically segmenting organs and lymph nodes using AI, generating synthetic CT images from MR and CBCT scans, computing dose distributions for radiation therapy, and aiding in treatment adaptation decisions. It enhances workflow efficiency and accuracy for trained professionals managing radiotherapy for cancer patients.

uOmnispace.MI is an advanced software platform designed to help healthcare professionals view and analyze medical images from PET, CT, MR, and SPECT scans. It facilitates tasks such as image registration, lesion segmentation, and statistical analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications including fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, thereby assisting clinicians in making timely and accurate diagnoses.

Syngo Carbon Clinicals is a software package that provides advanced visualization tools to help healthcare professionals prepare, measure, and analyze medical images from modalities such as CT and MRI. It supports manipulation and communication of clinical data, enabling qualitative and quantitative assessment to assist in diagnosis and treatment planning.