Device Overview
The NAEOTOM Alpha CT Scanner System is a computed tomography system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Indications for Use
The system is designed to aid in diagnosis and treatment, as well as for diagnostic and therapeutic interventions. It can also be used for low-dose lung cancer screening in high-risk populations.
Device Classification
The NAEOTOM Alpha is classified as a Class II device under 21 CFR 892.1750, with a product code of JAK.
Manual:
Download: 510(k) Summary for NAEOTOM Alpha CT Scanner System
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