FDA Radiology AI Devices

The Venue series from GE Medical Systems includes advanced ultrasound systems that use pulsed Doppler technology to help clinicians capture live images and blood flow information. These devices assist in diagnostic imaging by providing high-quality ultrasound scans useful in a variety of clinical applications.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices used by clinicians to perform detailed diagnostic examinations. They help visualize internal structures in the body using pulsed Doppler ultrasound, aiding in the assessment and diagnosis of various medical conditions.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

The 6600 Ultrasound System (MyLabA50 and MyLabA70) by Esaote is a multifunctional ultrasound scanner designed for use in various clinical applications such as cardiac, vascular, general imaging, and women's health. It uses advanced ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians collect, display, and analyze high-quality ultrasound images, supporting diagnosis and patient care. The system includes AI-powered features for automatic obstetric biometric measurements and automatic cardiac measurements, assisting clinicians by enhancing measurement accuracy and workflow efficiency.

DEEPECHO is a cloud-based AI software for fetal ultrasound image analysis. It helps trained healthcare professionals detect important fetal views in ultrasound scans and suggests caliper placement for accurate biometric measurements like head circumference and femur length. The software supports real-time image streaming and exam management to improve fetal assessment during pregnancy between 14 and 41 weeks, aiding clinicians to make informed decisions efficiently.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.

The 6450 Ultrasound System (MyLabE80 and MyLabE85) is a versatile diagnostic ultrasound machine designed for various clinical applications including cardiac, vascular, general imaging, and women's health. It supports multiple ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians visualize and assess internal body structures in real-time, aiding in diagnosis and treatment planning.

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.

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.