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.

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

FDA #
K233677
Product Code
KPS
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