FDA Radiology AI Devices

The TE Air Diagnostic Ultrasound System is a portable, general-purpose ultrasound device that uses wireless-connected probes and a mobile app to capture and display ultrasound images and Doppler flow information. It is intended for use by trained healthcare professionals to perform real-time ultrasound imaging, measurement, and analysis across a variety of anatomical regions and clinical applications, including fetal, abdominal, cardiac, musculoskeletal, thoracic, vascular, and urology exams. The system supports multiple imaging modes such as B-mode, M-mode, color and power Doppler, and tissue harmonic imaging, facilitating detailed internal body visualization and aiding diagnosis in clinics and hospitals.

Allix5 is a software tool that uses medical imaging data to help predict a patient's future risk of developing breast cancer. This helps clinicians identify patients who may need closer monitoring or preventive care.

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are surgical navigation tools that use fluoroscopic 2D and CT 3D imaging to precisely guide the placement of surgical instruments and implants during spine surgery. By registering images intraoperatively, they help surgeons perform accurate and safe spinal implant procedures, such as lumbar pedicle screw placement, improving surgical outcomes.

Radius VSM and Accessories is a wearable multi-parameter patient monitor from Masimo Corporation designed for continuous monitoring of vital signs like heart rhythm, blood pressure, oxygen saturation, respiratory rate, and skin temperature. It helps clinicians monitor patients' cardiovascular and respiratory status in hospital settings and includes arrhythmia detection, facilitating timely clinical intervention and patient management.

The Visualase V2 MRI-Guided Laser Ablation System is a neurosurgical tool designed to ablate, necrotize, or coagulate brain tissue including tumors and epileptic foci, using a laser controlled and monitored in real-time via MRI thermometry. It helps clinicians precisely target and treat affected brain areas in adults and pediatric patients aged 2 years and older.

The Voluson™ Performance 16 and Voluson™ Performance 18 are advanced diagnostic ultrasound systems designed for use by trained healthcare professionals to image, measure, display, and analyze human body structures and fluids. These systems support a wide range of clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, cardiac, vascular, musculoskeletal, and more. They provide real-time 3D/4D imaging, various Doppler modes, elastography, and have integrated AI features to assist in analysis. These systems enhance clinicians' ability to perform ultrasound examinations efficiently and with high image quality, aiding patient diagnosis and care.

The Zoom 7X Catheter, along with the Zoom Aspiration Tubing and Zoom POD Aspiration Tubing, is a sterile, single-use medical device designed to remove blood clots from large intracranial vessels in patients experiencing an acute ischemic stroke. It helps restore blood flow by aspirating the clot when connected to an aspiration pump, aiding clinicians in rapidly treating stroke and improving patient outcomes.

CoLumboX is a software tool that helps healthcare professionals analyze lumbar spine x-ray images by automatically segmenting and measuring spine features. It provides quantitative information and highlights out-of-range measurements to assist in clinical evaluations, supporting more efficient and accurate patient assessments without making diagnoses itself.

The Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.

The Flexible Ureteroscope (U-Scope) by Opcom Medical Inc. is a sterile, single-use, flexible digital video ureteroscope designed to visualize the urinary tract (including urethra, bladder, ureter, and kidney calyces) using a miniature CMOS camera and LED illumination. It connects to a reusable camera-controlled unit which processes and displays images and videos, enabling physicians to perform diagnostic and therapeutic procedures. This system aids clinicians by providing live, high-quality imaging to guide interventions in the urinary tract.