FDA Radiology AI Devices

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 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.

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.

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

The Mendaera Guidance System is an ultrasonic diagnostic transducer designed to assist clinicians in medical imaging procedures by providing real-time ultrasound images. It helps healthcare providers visualize internal structures, aiding in diagnosis and treatment guidance.

The Dental CBCT X-ray System by Yian Medical Technology is a dental imaging device that produces 2D panoramic, cephalometric images, and 3D cone-beam CT images of the dental, oral, and maxillofacial region. It aids healthcare professionals in diagnosing adult and pediatric patients, providing detailed digital X-ray images for dental and oral care.

The CT Scanner TSX-501R/1 V11.1 by Canon Medical Systems Corporation is an advanced computed tomography system that uses a photon counting detector to capture high-quality cross-sectional volume images of the whole body. This system helps clinicians perform specialized studies by providing detailed imaging data to support diagnosis and treatment planning for adult patients.

The SKR 3000 is a digital radiography device by Konica Minolta designed to produce high-quality X-ray images of the human body for general-purpose diagnostic procedures. It replaces traditional film-based systems and includes features like advanced image processing and wireless connectivity. Its added indication includes pediatric imaging, helping clinicians accurately diagnose patients of all ages.

The EXTRON series (EXTRON 3, EXTRON 5, EXTRON 7) are mobile fluoroscopic X-ray systems that provide high-quality, real-time X-ray images to support clinicians during emergency injury treatment, orthopedic surgery, neurosurgery, and other interventions. The system includes advanced image processing capabilities and enables saving and transferring images to hospital PACS, improving diagnosis and workflow in surgical settings.