FDA Radiology AI Devices

The Alphenix INFX-8000V is an interventional fluoroscopic X-ray system designed by Canon Medical Systems Corporation. It provides real-time X-ray imaging to assist clinicians during interventional procedures, allowing enhanced visualization of anatomy and devices, thereby improving procedure accuracy and patient care.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that help clinicians visualize and assess various body regions using pulsed Doppler technology. These systems support medical diagnosis by providing high-quality ultrasound images and measurements, facilitating patient care in many clinical settings.

The Lux HD 2530 detector is a digital flat panel X-ray imager used in radiology to capture high-quality X-ray images. It helps clinicians obtain detailed radiographic images for diagnosis and treatment planning with improved image quality over traditional detectors.

The GT300 and GT300-C are dental computed tomography (CT) devices used in radiology to produce detailed X-ray images of the teeth and jaw. These devices assist clinicians in diagnosing and planning treatment by providing high-resolution images of dental structures.

ProKnow DS is an image processing system designed to assist clinicians by managing, analyzing, and improving the workflow of radiological image data. It helps healthcare professionals efficiently handle medical images to enhance patient care.

AIAS Cephalon by metamorphosis GmbH is an AI software tool designed to assist in processing radiological images automatically, helping clinicians analyze medical images more efficiently and accurately.

HPACS is an image processing system designed for radiology that helps clinicians by enhancing and managing medical images, potentially improving diagnosis and workflow efficiency.

The Bunkerhill MAC is a computed tomography system that uses X-rays to produce detailed images of the body's internal structures. This device assists clinicians by providing high-resolution tomographic images to aid in diagnosis and treatment planning.

LungQ 4 is a computed tomography-based medical imaging product designed to assist clinicians in analyzing lung images. It provides AI-driven insights that help in the detection and assessment of lung conditions, improving diagnostic accuracy and patient management in radiology departments.

Philips IntelliSpace Cardiovascular is a medical image processing system designed to assist clinicians in analyzing cardiovascular images. It facilitates improved visualization and assessment of heart-related conditions to support patient diagnosis and treatment planning.