FDA Radiology AI Devices

Voxel Dosimetry is a software tool used in nuclear medicine to calculate the absorbed radiation dose distribution within a patient's body at the small voxel level and for specific organs. It uses deep learning based semi-automatic segmentation and non-rigid image registration to analyze images post-radionuclide therapy, providing clinicians with detailed dose mapping to assist in treatment planning and evaluation.

The Cios Spin is a mobile fluoroscopic C-arm X-ray system designed for use in surgical environments. It enables clinicians to acquire detailed X-ray images during various procedures such as orthopedic, vascular, neurologic, and emergency room interventions. The system provides 3D image acquisition capabilities and integrates with navigation software to help clinicians accurately visualize anatomical structures, thereby enhancing procedural precision and patient care.

The PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS are portable digital X-ray systems designed to provide high-quality diagnostic images of body extremities. These battery-operated portable X-ray devices use flat-panel detectors and advanced image acquisition software to produce clear, digital radiographs, aiding fast and accurate clinical diagnosis. They are intended for use in varied healthcare settings including field locations and tele-radiology setups, operated by trained medical professionals.

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.