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.

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 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.

Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system. It automatically segments the median nerve and measures its cross-sectional area in ultrasound images of the wrist and forearm. This tool assists trained healthcare professionals by providing semi-automated measurements to support clinical assessment in musculoskeletal ultrasound imaging, improving efficiency and accuracy while allowing manual adjustments.

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.

BrightHeart View Classifier is an AI-powered software that automatically analyzes fetal ultrasound images and video clips to identify standard views of the fetal heart during scans. It helps healthcare professionals by improving the acquisition and interpretation of fetal heart ultrasound exams, making fetal heart imaging more efficient and consistent.

Fetal EchoScan (v1.1) is an AI-driven software device that assists physicians in interpreting second-trimester fetal heart ultrasound videos. It detects suspicious morphological features indicative of congenital heart defects, helping clinicians identify potential heart abnormalities in unborn babies during routine ultrasound exams. The software acts as a concurrent reading aid, providing annotative outputs to improve diagnostic accuracy and support clinical decision-making for fetal cardiac assessment.

Vscan Air is a pocket-sized, battery-operated ultrasound imaging system designed for use by trained healthcare professionals. It operates wirelessly with a mobile app and provides ultrasound images and measurements across many clinical areas including abdominal, cardiac, obstetrics, musculoskeletal, and vascular applications. The device incorporates AI features to enhance diagnostic accuracy and assist clinicians, such as automatic bladder volume measurement using deep learning, and real-time guidance for cardiac imaging.

The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.