(91 days)
The CT ProSpeed CT/i is indicated for head and whole body xray computed tomography applications. It provides axial, helical and scout imaging.
The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories.
This document is a 510(k) summary for a CT scanner (CT ProSpeed CT/i). It focuses on demonstrating substantial equivalence to previously marketed devices and ensuring safety. It does not contain information on the acceptance criteria, study design, or performance metrics typically associated with AI/algorithm-driven devices. Therefore, I cannot extract the requested information from the provided text.
Specifically, the document from 1996 describes a computed tomography (CT) scanner, a hardware device for medical imaging, not an AI or algorithm-driven software device. The acceptance criteria and performance data requested (e.g., sensitivity, specificity, MRMC studies, ground truth establishment) are relevant to software algorithms, particularly those involved in image analysis or diagnosis. These types of studies were not typically performed or reported in 510(k) submissions for hardware imaging devices like CT scanners in 1996.
Therefore, the requested information cannot be filled from the provided text.
§ 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.