FDA Radiology AI Devices

The Philips Lumify Diagnostic Ultrasound System is a portable medical ultrasound device that allows clinicians to capture high-resolution ultrasound images and analyze blood flow in various body regions. It supports multiple imaging modes and is compatible with mobile devices, helping healthcare professionals perform diagnostic ultrasound in many clinical applications, including obstetrics, gynecology, musculoskeletal, cardiac, and vascular imaging. The addition of the C9-4ec transducer expands its use to trans-vaginal imaging and fertility assessments, improving diagnostic capabilities in reproductive health.

Medical Image Post-processing Software (uOmnispace.CT) is sophisticated software designed to help radiologists and clinicians view, manipulate, evaluate, and analyze CT medical images. It includes multiple specialized processing applications for lungs, heart, brain, liver, bone structure, vascular structures, and more, helping clinicians quantify and characterize anatomical and functional information to support diagnosis and treatment planning.

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.

Smile Dx® is an AI-powered software that assists dentists by analyzing dental X-ray images to detect issues like cavities, periapical radiolucencies, restorations, and measures bone levels. It supports digital and phosphor sensors, enhancing diagnosis and treatment planning by highlighting suspected dental findings for review, but it does not replace a dentist's judgment.

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.

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 P-Cure Proton Therapy System (PPTS) is a medical device that produces and delivers proton beam radiation to treat patients with localized tumors and conditions in the head, neck, and thorax. It improves treatment accuracy by using advanced image-guided and robotic patient positioning, including CT and X-ray imaging, helping clinicians precisely target tumors while minimizing damage to surrounding tissues.

The SPECTRALIS HRA+OCT and variants by Heidelberg Engineering GmbH are non-contact ophthalmic imaging devices combining confocal laser-scanning ophthalmoscopy and spectral-domain optical coherence tomography (SD-OCT). They capture detailed cross-sectional and angiographic images of the eye, aiding clinicians in diagnosing and managing various ocular diseases such as macular degeneration, diabetic retinopathy, and glaucoma. These devices enhance visualization of ocular anatomy and vascular structures, improving clinical evaluation and patient care.

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 EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC provide advanced ultrasound imaging and fluid flow analysis for various body regions, including cardiac adult imaging. These systems incorporate AI-driven software features such as Segmental Wall Motion Version 2 (SWM v2) and Auto EF with contrast, which assist clinicians in automating the evaluation of left ventricular function and ejection fraction using transthoracic echocardiography. This helps healthcare providers make more accurate and efficient cardiac assessments during diagnostic imaging.