FDA Radiology AI Devices

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.

Sleepiz One+ (2.5) is a contactless medical device that uses Doppler radar technology to measure heart rate and respiration rate in adult patients at rest or during sleep. It detects patient presence and body movements, allowing healthcare professionals to monitor these vital signs remotely either in clinical or home settings through cloud-based software. It aids clinicians by providing continuous non-contact monitoring without the need for wearable devices or electrodes.

The MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System is a wearable cardiac monitoring device for patients with suspected arrhythmias. It captures ECG data through a sensor pod with leads or a patch, which is wirelessly transmitted to a mobile gateway and then to a cloud-based software platform for analysis using proprietary algorithms. This helps physicians detect and monitor cardiac arrhythmias, aiding in diagnosis and treatment decisions without requiring patient intervention during use.

Marie is a computed tomography (CT) X-Ray system designed to capture detailed cross-sectional images of the body, aiding clinicians in diagnosing and monitoring various medical conditions through advanced imaging techniques.

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 Confocal Microprobe Imaging System by Wuxi Hisky Medical Technologies is a high-resolution optical imaging device used in general and plastic surgery. It helps clinicians obtain detailed images of tissue microstructures during procedures, improving diagnosis and surgical outcomes.

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.

IMAGE ONE is a radiological image processing system developed by Infomed Software. It aids clinicians by processing medical images to enhance their interpretation and support diagnostic decisions.

Neuro Insight V1.0 by Olea Medical S.A.S. is an advanced image processing system designed for radiological applications. It helps clinicians by processing medical images, potentially enhancing the insight gained from them for neurological assessments.

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.