FDA Radiology AI Devices

Viewer+ is an internet browser-based software intended to help pathologists view and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It aids in primary diagnosis by allowing image navigation, annotation, and measurement, ultimately supporting pathology evaluations digitally.

PLANET Onco Dose (3.2) is a specialized software platform designed for medical professionals in molecular imaging and oncology. It helps manage and analyze various anatomical and functional medical images such as CT, MRI, SPECT, PET, and others. The software supports tumor and normal tissue segmentation, image co-registration, therapy response evaluation, and computes radiation doses at a voxel level for radionuclide-based therapies, improving treatment planning and patient care.

The xvision Spine system by Augmedics Ltd. is an advanced surgical navigation system that helps surgeons precisely locate anatomical structures in the spine during open or percutaneous procedures. By integrating near-eye augmented reality displays with fluoroscopic and CT images, it enables real-time visualization of tracked surgical instruments overlaid on patient anatomy, improving accuracy for procedures such as pedicle screw and iliosacral screw placement. This technology enhances surgical precision and safety, aiding clinicians in complex spine surgeries.

The FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.

Ziehm Vision FD is a mobile fluoroscopic X-ray system designed to provide continuous and pulsed fluoroscopic imaging during diagnostic, interventional, and surgical procedures. It helps clinicians visualize complex anatomical structures such as vascular, cardiac, and neurologic areas in real-time to better localize and treat pathological regions, improving accuracy in surgical and critical care settings. The system offers high-resolution flat panel displays, motorized and manual movement axes for precise positioning, and supports multiple peripheral interfaces, enhancing surgical workflow and patient care.

The RCT600 is a dental and maxillofacial imaging system that uses cone beam computed tomography (CBCT), panoramic, and cephalometric X-ray imaging to help dentists and healthcare professionals diagnose and plan treatment for both adult and pediatric patients. It produces high-quality 3D and 2D images of hard tissues like bones and teeth, as well as wrist images for orthodontic growth assessment, enabling better clinical decisions and patient care.

The 2430TCA with Xmaru W is a digital flat panel X-ray detector system designed for mammographic screening. It replaces traditional film or screen-based mammographic systems by capturing and digitizing high-quality breast images, assisting clinicians in breast cancer screening with enhanced image quality and reduced noise.

Better Diagnostics Caries Assist (BDCA) Version 1.0 is an AI-powered software tool that helps dentists automatically identify and mark areas of tooth decay (caries) on dental x-rays (bitewing and periapical). It provides visual annotations to support the dentist's diagnosis, improving the accuracy and efficiency of caries detection but does not replace clinical judgment or complete review.

The Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter is a reprocessed ultrasound catheter designed for imaging inside the heart and great vessels of adult patients. It assists clinicians by providing intracardiac and intraluminal visualization using the ultrasound modality. The catheter is intended for imaging guidance during cardiac interventional procedures, improving visualization of cardiac anatomy and device placement without treatment delivery.

The SPINEART Navigation Instrument System is a surgical tool used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws. It integrates with the eCential Op.n PERLA® TL Navigation System, which uses intraoperative 3D imaging, to improve surgical precision in both open and minimally invasive procedures.