FDA Radiology AI Devices

The TruSPECT Radiological Image Processing Station is a nuclear medicine imaging software system designed to process and display SPECT images alongside CT/MR scans for enhanced clinical diagnosis, including attenuation correction and quantitative assessment. It supports AI-based attenuation correction to improve image quality and aids clinicians, particularly for cardiac imaging and other clinical applications, by providing advanced visualization, segmentation, and quantitative tools.

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.

QMENTA Care Platform Family is a software system that helps hospitals and clinicians receive, store, and analyze medical images from CT, MRI, and PET/CT scans. It integrates multiple AI-powered applications to process these images, assisting doctors in diagnosing by providing advanced image analysis and organized data accessible over a network.

SubtleMR is a software tool that enhances MRI images by reducing noise or increasing sharpness using a convolutional neural network algorithm. It works with various MRI scans of the head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal areas to help radiologists obtain clearer images for better interpretation and diagnosis.

QUIBIM Precision Prostate (qp-Prostate) is software designed to assist trained professionals such as radiologists in viewing and analyzing prostate MRI scans. It offers advanced post-processing features to quantify diffusion and perfusion characteristics, helping clinicians better visualize prostate tissue and complete structured reports. This software enables improved image analysis and decision support without performing a direct diagnostic function.

AI Metrics is a software-based medical imaging tool that helps clinicians view, annotate, and analyze images from multiple modalities and time points. It automates workflow steps in assessing diseases and monitoring response to therapy according to standards like RECIST 1.1, supporting clinical interpretations and documentation in radiology and oncology settings. Importantly, it assists but does not replace the physician's diagnosis process.

AI-Rad Companion Engine is a software platform that supports visualization and post-processing of medical images for diagnostic use, helping clinicians by facilitating measurement, analysis, and data management. It integrates with multiple imaging modalities and PACS systems, providing an interface to add additional AI-driven clinical processing extensions.

PhantomMSK Trauma is a software tool that helps surgeons during orthopedic trauma surgeries by providing precise measurements and image analysis of fluoroscopic images. It assists in the intraoperative positioning of implants relative to bone structures, helping improve surgical accuracy without primary image interpretation.

Merge PACS is a software system that helps medical professionals view, analyze, and manage images from various medical imaging modalities such as CT, MRI, PET, ultrasound, and mammography. It supports diagnostic reading, reporting, and communication workflows, enabling clinicians to efficiently handle patient imaging studies and related data. It includes advanced image manipulation tools and workflow management features to assist radiologists and other medical staff.

SubtleMR is a software device that enhances MRI images by reducing noise or increasing image sharpness using a convolutional neural network algorithm. It supports MR images from 1.2, 1.5, and 3 Tesla scanners and helps radiologists by improving image quality without requiring a user interface. This enhancement assists clinicians in better visualization of anatomical details for diagnosis and treatment planning.