(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.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular shape. Three arrow-like shapes are arranged around the circle, suggesting motion or circulation. The logo is presented in black and white.
JUN 17 1996
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Summary of Safety & Effectiveness 15 March 1996
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h) .
Contact : Larry Kroger 414-544-3894 Phone: 414-544-3863 Fax:
Product Identification:
| Name: | CT ProSpeed CT/i |
|---|---|
| Manufacturer: | GE - Yokogawa Medical Systems7-127 Asahigaoka, Hino-shi4-chome, Tokyo 191, Japan |
| Distributor: | GE Medical Systems3000 N. GrandviewWaukesha, WI 53188 |
Indications for Use:
The CT ProSpeed CT/i is indicated for head and whole body xray computed tomography applications. It provides axial, helical and scout imaging.
Device Description:
The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories.
Materials: Materials and construction are equivalent to the CT ProSpeed Plus and are compliant with UL 187, IBC 601-1, and 21 CFR Subchapter J.
Design: The design is essentially the same as the CT ProSpeed with HiLight Detector (K944013) the difference being that it uses a computer workstation user interface similar to our HiSpeed CT/i (K 940606).
Energy Source and Exposure Levels: The energy source is can be over the range of 208 to 480 Vac 50/60 Hz.
- 3.5MHU tube capacity,
- high frequency on-board generator
- 42kW output power
CTDI at 120kVp, 300 mAs, 1s scan for body, 1.5 s scan for head, 10mm aperture:
Center : Head 60 mGy (6.0 Rad) Body 17 mGy (1.7 Rad) Surface: Head 62 mGy (6.2 Rad) Body 31 mGy
(3.2 Rad)
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Marketing History:
It is the opinion of GE Medical Systems that the ProSpeed CT/i is of a comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a hazard analysis and controlled by:
Failure Mode Effects Analysis to demonstrate the . non-existence or extremely low probability of unwanted events .
System evaluation to insure performance to . specifications and Federal Regulations.
Adherence to Industry and International Standards. . (UL and IEC)
Conclusions :
Use of the ProSpeed CT/i does not result in any new potential safety risks.
§ 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.