FDA Radiology AI Devices

The Ziehm Solo FD is a mobile fluoroscopic X-ray imaging device designed for both adult and pediatric patients. It provides real-time pulsed and continuous fluoroscopic imaging to assist clinicians during diagnostic, interventional, and surgical procedures across various specialties such as orthopedics, neurology, vascular, and cardiac care. The device enhances visualization of anatomical structures, helping improve clinical outcomes through high-quality digital images and cine loops capture.

The FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.

Ziehm Vision FD is a mobile fluoroscopic X-ray system designed to provide continuous and pulsed fluoroscopic imaging during diagnostic, interventional, and surgical procedures. It helps clinicians visualize complex anatomical structures such as vascular, cardiac, and neurologic areas in real-time to better localize and treat pathological regions, improving accuracy in surgical and critical care settings. The system offers high-resolution flat panel displays, motorized and manual movement axes for precise positioning, and supports multiple peripheral interfaces, enhancing surgical workflow and patient care.

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are medical devices designed to assist in the revascularization of patients experiencing acute ischemic stroke caused by large vessel occlusions in the brain. The catheter is used alongside a compatible aspiration pump to remove blood clots from the affected neurovasculature, helping to restore blood flow. This device is intended for use within 8 hours of stroke symptom onset and for patients who have not responded to or are ineligible for thrombolytic drug therapy.

3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

The Penumbra System (Reperfusion Catheter RED 72) is a catheter-based device designed to remove blood clots in the brain's large vessels to treat acute ischemic stroke. It uses aspiration to restore blood flow in blocked intracranial vessels during neurointerventional procedures, guided by fluoroscopy. This device helps clinicians revascularize patients who are ineligible or have failed thrombolytic drug therapy, improving stroke treatment outcomes.

The Ziehm Vision RFD 3D is a medical imaging device that provides high-quality 2D and 3D fluoroscopic X-ray images during surgical and diagnostic procedures. It helps clinicians visualize complex anatomical structures such as bones, joints, and soft tissues in real-time, improving outcomes in orthopedic, neurological, trauma, and other surgeries. The system supports computer-assisted surgery by providing detailed imaging and C-arm positioning data, facilitating safer and more accurate interventions.

The Ziehm Vision RFD is a mobile fluoroscopy system with a flat panel detector used to provide real-time digital imaging during diagnostic and interventional surgical procedures. It helps clinicians visualize complex anatomical structures in various body regions including the spine, joints, and cardiovascular system, aiding in procedures such as cardiology, orthopedics, neurology, and more. The device offers advanced digital subtraction and cine imaging, enhancing image quality and surgical navigation accuracy to improve clinical outcomes for patients.

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.

The Soteria E-View is a fluoroscopic and radiographic X-ray imaging system designed for use in general and pediatric populations. It provides real-time imaging during interventional procedures, helping clinicians visualize patient anatomy effectively. It integrates advanced flat panel detector technology and radiation safety controls to reduce exposure while delivering high-quality images for diagnostic and interventional use.