FDA Radiology AI Devices

OTS Hip is an orthopedic surgical system designed to aid surgeons in preoperative planning and intraoperative navigation of hip replacement surgeries. It uses CT and X-ray medical imaging data and combines software and hardware components to create a 3D model of the patient's unique anatomy, guiding surgical instrument and prosthetic placement in real-time. This helps improve the accuracy and safety of total hip arthroplasty procedures.

CaloPix is a software-only digital pathology image management system designed to help pathologists view, interpret, and manage whole slide images from scanned surgical pathology slides of formalin-fixed paraffin embedded tissue. It supports detailed image review including panning, zooming, annotation and measurement and integrates with laboratory systems to organize pathology cases digitally. The software assists clinicians in efficiently handling large digital slide datasets to aid in primary diagnosis.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 by Canon Medical Systems is a diagnostic ultrasound device that uses advanced imaging modes like Doppler, elastography, and speckle tracking to provide high-quality ultrasound images of various body parts including fetal, abdominal, cardiac, and musculoskeletal regions. It aids clinicians by providing detailed images to support diagnosis and clinical evaluation in hospitals and clinics.

uWS-Angio Basic is medical image management and processing software designed to handle X-ray angiographic, CT, and MRI images. It provides clinicians with tools for viewing, processing, calibration, and measurement of 2D and 3D vascular images, supporting improved diagnosis and treatment planning in angiography and related procedures.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a medical device designed to image the inside of coronary and peripheral blood vessels using ultrasound. It provides real-time cross-sectional images to help clinicians evaluate vessel morphology as an adjunct to angiography, aiding in diagnosis and treatment planning for cardiovascular conditions.

The VeriSight Intracardiac Echocardiography Catheters (VSICE2D and VSICE3D) are disposable devices used during cardiac procedures to provide real-time ultrasound imaging inside the heart and nearby vessels. They help clinicians visualize cardiac anatomy and physiology in both adult and pediatric patients for guidance during interventions, improving the accuracy and safety of heart treatments.

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a mobile, software-controlled ultrasound imaging device that supports various imaging modes including B-mode, Color Doppler, Pulsed Wave Doppler, and M-mode. It is designed for diagnostic ultrasound imaging and fluid flow analysis across many anatomical areas such as fetal, abdominal, musculoskeletal, cardiac, ophthalmic, and more. The device is compatible with iOS and Android systems and includes different USB transducers. The recent update adds an ocular preset to enable ophthalmic imaging, expanding its clinical utility. This portable ultrasound system helps clinicians obtain high-resolution images and flow data to support diagnosis and procedural decisions.

The Ultrasound Imaging System (LU700, 128, and LX Series) by Leltek Inc. is a portable, software-controlled ultrasound system that runs on commercial mobile devices. It uses wireless transducers communicating over Wi-Fi to acquire and display real-time, high-resolution ultrasound images across multiple modes such as B-mode and Doppler modes. It aids clinicians in evaluating various body regions and conditions by providing versatile imaging capabilities tailored for different probes and clinical applications.

The !M1 mobile X-ray system by Solutions for tomorrow AB is a diagnostic mobile X-ray system designed to perform general radiography exams on pediatric and adult patients in healthcare facilities. It utilizes digital radiography technology with flat-panel detectors, offering configurations with detectors from manufacturers like Canon, Konica Minolta, and Vieworks, improving image quality and system performance. This helps clinicians obtain diagnostic images efficiently both inside and outside standard X-ray rooms, improving patient care.

The Arthrex Synergy Vision Endoscopic Imaging System is an advanced camera system used in endoscopic surgery to provide live imaging in visible and near-infrared light. It helps surgeons visualize vessels, blood flow, lymphatic system, and tissues during minimally invasive surgeries, improving surgical precision and patient outcomes.