FDA Radiology AI Devices

This product is a series of diagnostic ultrasound systems used to capture real-time images of the body's internal structures, helping clinicians diagnose and monitor various medical conditions. It supports multiple models designed for different imaging needs and clinical environments.

The ACUSON Sequoia and ACUSON Origin Diagnostic Ultrasound Systems by Siemens are advanced ultrasound imaging devices used by clinicians to visualize internal structures of the body in real-time. They help in diagnosing a variety of conditions by providing high-quality ultrasonic images, aiding patient care through non-invasive and versatile imaging.

The Deepsight NeedleVue LC1 Ultrasound System is an imaging device that uses pulsed echo ultrasound technology. It helps clinicians visualize internal anatomy in real-time to guide procedures such as needle placements more accurately and safely.

The Single Use Aspiration Needle models NA-201SX-4021 and NA-201SX-4022 by Olympus Medical Systems are sterile, disposable needles used alongside ultrasound endoscopes to perform fine needle aspiration of submucosal and extramural lesions in the tracheobronchial tree. They help clinicians obtain tissue samples safely and effectively under real-time ultrasound guidance.

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.

TINGSN FINDERS 2 is a color Doppler ultrasound system that helps clinicians visualize and assess blood flow and heart function using pulsed Doppler ultrasound technology. It assists in cardiovascular diagnosis by providing detailed images and flow information in real time.

The V series Diagnostic Ultrasound System by Samsung Medison is an advanced ultrasound imaging device that helps clinicians visualize internal body structures using pulsed Doppler ultrasound. This assists in diagnosing and monitoring various medical conditions by providing real-time images and data of tissues and blood flow.

EchoPAC Software is a tool developed by GE Medical Systems that processes ultrasound images to assist clinicians in analyzing echocardiography data. It helps in improving workflow efficiency and accuracy in cardiac ultrasound interpretation.

The B-Scan device by ACCUTOME, INC. is an ultrasound imaging system that uses pulsed echo technology to capture images inside the body. It assists clinicians by providing detailed images useful for diagnosis and treatment planning in radiology.