(13 days)
The Hispeed CT/e Dual Computed Tomography System is indicated for head and whole body X-ray Computed Tomography applications.
The Hispeed CT/e Dual Computed Tomography system consist of a gantry, patient support, operator console ,computer and associated accessories.
This document is a 510(k) summary for the GE Healthcare Hispeed CT/e Dual Computed Tomography system. It asserts substantial equivalence to existing devices and outlines the device's intended use and safety standards. However, it does not contain information regarding detailed acceptance criteria, a study proving performance against such criteria, or any data related to AI/algorithm performance.
Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating device performance based on the input text. The document focuses on regulatory compliance and substantial equivalence, not detailed performance studies or AI aspects.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.