FDA Radiology AI Devices

The Biograph Vision and Biograph mCT PET/CT systems from Siemens are advanced imaging machines that combine CT and PET technologies to produce high-resolution images showing both anatomical structures and physiological functions. These systems help healthcare professionals detect, localize, diagnose, and stage various diseases including cancer, cardiovascular, and neurological disorders, and also assist with radiotherapy and interventional procedures.

The Biograph Horizon is a medical imaging system that combines positron emission tomography (PET) and computed tomography (CT) to provide detailed metabolic and anatomical images of the body. It helps clinicians in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular, and neurological disorders by fusing high-resolution functional and anatomical data, thereby improving treatment planning and clinical decision-making.

MRCAT brain is a software add-on for Philips Ingenia MR systems that generates CT-like images from MR scans to assist in radiation therapy treatment planning for brain tumor patients. It helps clinicians by providing detailed tissue density maps necessary for accurate radiation dose calculations without the need for a separate CT scan.

PhantomMSK Trauma is a software tool that helps surgeons during orthopedic trauma surgeries by providing precise measurements and image analysis of fluoroscopic images. It assists in the intraoperative positioning of implants relative to bone structures, helping improve surgical accuracy without primary image interpretation.

Merge PACS is a software system that helps medical professionals view, analyze, and manage images from various medical imaging modalities such as CT, MRI, PET, ultrasound, and mammography. It supports diagnostic reading, reporting, and communication workflows, enabling clinicians to efficiently handle patient imaging studies and related data. It includes advanced image manipulation tools and workflow management features to assist radiologists and other medical staff.

The CS-series-FP Radiographic / Fluoroscopic System with the optional CA-100S / FluoroShield ROI Assembly is an advanced fluoroscopic X-ray system that automatically manages and reduces radiation exposure by focusing on a configurable region of interest (ROI) during imaging. It blends high-resolution live imaging of the ROI with lower-exposure peripheral imaging, thus improving image quality and reducing unnecessary radiation dose to both patients and medical staff during interventional procedures.

SubtleMR is a software device that enhances MRI images by reducing noise or increasing image sharpness using a convolutional neural network algorithm. It supports MR images from 1.2, 1.5, and 3 Tesla scanners and helps radiologists by improving image quality without requiring a user interface. This enhancement assists clinicians in better visualization of anatomical details for diagnosis and treatment planning.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that connects wirelessly to iOS or Android devices to provide high-resolution, real-time diagnostic ultrasound and Doppler imaging. It supports multiple clinical applications such as abdominal, cardiac, musculoskeletal, fetal, and procedural guidance, helping clinicians perform ultrasound imaging conveniently in diverse healthcare settings.

ClariCT.AI is a software tool designed to process and enhance CT scan images by reducing noise and improving image clarity. It supports images from various CT scanner manufacturers and helps clinicians by providing improved image quality, especially in low-dose CT scans, facilitating better diagnostic confidence without additional radiation exposure.

SurgicalAR is a software platform that allows clinicians to view and manipulate medical images in both traditional 2D and advanced 3D formats, including augmented reality via head-mounted displays. It aids surgical planning and medical image review by providing tools such as image manipulation, measurements, and 3D visualization of CT and MR images. This enhances the understanding of complex anatomical structures to improve clinical decision making.