FDA Radiology AI Devices

Ligence Heart is an automated software designed to assist clinicians by processing radiological images of the heart. It helps by analyzing cardiac imaging data to support medical diagnosis or evaluation.

BriefCase-Triage: CARE Multi-Triage CT is an AI software that helps clinicians by automatically analyzing CT images to detect critical conditions like pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fractures or dislocations, enabling faster diagnosis and treatment.

The KARL STORZ ICG Imaging System with RUBINA® Lens is an advanced medical imaging device that uses near-infrared fluorescence (indocyanine green, ICG) combined with confocal optical imaging to help surgeons visualize blood flow and tissue perfusion during surgery. This enhances surgical precision and patient outcomes by providing real-time images of vascular structures and tissue viability.

IntraSight Plus is an ultrasound imaging system designed for cardiovascular use. It helps clinicians visualize blood vessels and heart structures, potentially enhancing diagnosis and treatment planning in cardiovascular care.

AI Platform 2.2 (AIP002) is an automated software designed to process radiological images, helping clinicians by improving the efficiency and accuracy of image interpretation in medical diagnostics.

The AirRay-mini series are mobile X-ray systems designed for radiology use. These devices help clinicians capture X-ray images conveniently, which can be used to diagnose various conditions and support patient care, particularly in settings where mobility is important.

MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are MRI systems developed by Siemens Shenzhen Magnetic Resonance, Ltd. These devices perform nuclear magnetic resonance imaging, providing high-quality images that help clinicians diagnose and monitor patient conditions non-invasively.

The Ingenia series of MRI systems by Philips Medical Systems are advanced devices used to create detailed images of the body's internal structures. These MRI systems assist clinicians by providing high-quality scans that can be used for diagnosing a wide range of medical conditions across different anatomical regions.

SKIA-Head (Model: SKIA-ST00) is a radiological image processing system designed to assist clinicians by enhancing, analyzing, or aiding interpretation of medical images in radiology. This system helps improve diagnostic accuracy and efficiency for imaging of the head region.

The CARA System is an interventional fluoroscopic X-ray system used in radiology to provide real-time imaging during procedures. It helps clinicians visualize anatomy and guide interventions effectively.