FDA Radiology AI Devices

The PRORAD X-Ray Flat Panel Detector with DROC is a digital radiography system designed to capture and display X-ray images of human anatomy. It is intended for general projection radiographic applications and helps clinicians by digitizing X-ray images for faster, more flexible image viewing and processing. The detector incorporates software that supports image workflow, viewing, measurement, and DICOM connectivity, streamlining radiographic exams and image management in clinical settings.

Change Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.

Hybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.

The IODR1717 / IODR1417 / IODR1417-GF detectors are digital flat panel X-ray detectors designed for high-quality digital radiography in general anatomical imaging for adults and children. They replace film-based systems and facilitate faster, streamlined digital radiography with wireless or wired connectivity, enhancing image acquisition and processing for clinicians.

The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.

eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.

The Edison System is a non-invasive focused ultrasound device designed to mechanically destroy liver tumors using a non-thermal process called histotripsy. Integrated with diagnostic ultrasound imaging, it assists clinicians in precisely targeting and treating liver tumors without surgery, helping to improve liver cancer patient outcomes.

MetaLite DX Digital Pathology Software is a software-only medical device that helps pathologists view, interpret, and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It facilitates digital pathology diagnosis by providing tools for image viewing, zooming, measurements, and annotation, designed to enhance workflow with specific scanners and displays, thereby aiding in accurate and efficient pathology diagnosis.

VistaPano S Ceph 2.0 and related models are advanced 2-in-1 digital X-ray imaging systems designed to capture detailed panoramic and cephalometric images of the dento-maxillofacial region, sinus, and TMJ for adult and pediatric patients. It supports orthodontic treatment by also using carpal images. The systems are intended to be operated by medical professionals such as dentists, physicians, and x-ray technicians, improving diagnostic capabilities in dental and maxillofacial care.