FDA Radiology AI Devices
Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.
Cartesion Prime (PCD-1000A/3) V10.8 is a diagnostic imaging system that combines Positron Emission Tomography (PET) and multi-slice Computed Tomography (CT). It provides fused images to help clinicians assess metabolic and functional information for evaluating oncological, cardiovascular, and neurological diseases. The device incorporates an AI algorithm called AiCE-i that improves PET image quality and reduces noise using deep learning methods, facilitating better diagnosis and treatment planning.
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