Overview
The SOMATOM go. Platform and SOMATOM X Platform CT Scanner Systems are computed tomography (CT) systems designed to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data.
Indications for Use
The systems are intended for use in diagnosis, treatment, and radiation therapy planning, as well as for diagnostic and therapeutic interventions. They can also be used for low-dose lung cancer screening in high-risk populations.
Device Classification
The systems are classified as Computed Tomography X-ray Systems, regulated by 21 CFR 892.1750, and are classified as Class II devices with product code JAK.
Manual:
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