FDA Radiology AI Devices

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.

The Self-Propelled CT Scan Base Kit, combined with the Alphenix system and its software, provides advanced computed tomography imaging capabilities. It helps clinicians capture detailed cross-sectional images of patients to assist in diagnosis and treatment planning.

CT:VQ by 4DMedical Limited is a medical imaging system that uses computed tomography (CT) technology to help clinicians visualize and assess the lungs and ventilation. It supports diagnosis and treatment planning by providing detailed ventilation imaging and analysis based on CT scans.

The Revolution Vibe is a computed tomography (CT) imaging system developed by GE Medical Systems. It captures detailed cross-sectional X-ray images of the body, aiding clinicians in diagnosing and monitoring various conditions with high clarity and speed.

Marie is a computed tomography (CT) X-Ray system designed to capture detailed cross-sectional images of the body, aiding clinicians in diagnosing and monitoring various medical conditions through advanced imaging techniques.

The SOMATOM go series by Siemens Medical Solutions USA, Inc., comprises advanced CT scanner systems used in radiology to produce detailed cross-sectional images of the body. These devices assist clinicians by providing high-quality computed tomography images that support diagnosis and treatment planning for various medical conditions.

The Philips iCT CT System is a computed tomography scanner designed for diagnostic imaging of the head, body, cardiac, and vascular regions. It produces detailed cross-sectional images by reconstructing X-ray data taken from multiple angles, aiding clinicians in diagnosing a range of conditions. The system offers updated hardware and software improvements for enhanced image quality, cybersecurity, and usability without altering its core imaging capabilities.

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.

CardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.