FDA Radiology AI Devices

This product group from Philips Ultrasound, Inc. includes several series of diagnostic ultrasound systems and software that produce and analyze ultrasound images to assist clinicians in diagnosing various conditions. They support 2D, Doppler, and advanced imaging modes for applications across many body regions, improving clinical workflow and diagnostic confidence.

Caption Guidance is an AI-powered software that assists healthcare professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance similar to an expert sonographer, helping to capture standard echocardiographic views accurately and efficiently during 2D transthoracic echocardiography.

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.

Caption Guidance is an AI software accessory for ultrasound systems that helps clinicians, including those without specialized training, acquire high-quality cardiac ultrasound images. It provides real-time feedback and prescriptive guidance to optimize the capture of diagnostic standard 2D echocardiographic views, supporting quicker and more reliable heart assessments.

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.