(91 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The description focuses on standard CT scanner components and imaging modes.
No
Explanation: The device is described as an x-ray computed tomography scanner used for diagnostic imaging, not for treating diseases or conditions. Its intended use is for "head and whole body xray computed tomography applications," which points to an imaging/diagnostic purpose.
Yes
The device is an x-ray computed tomography scanner indicated for head and whole body imaging, which is a diagnostic imaging modality used to generate images for medical diagnosis.
No
The device description explicitly states it consists of hardware components like a gantry, patient table, console, and computer, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "head and whole body xray computed tomography applications." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions.
- Device Description: The description details components of an imaging scanner (gantry, patient table, console, computer), which are typical for CT scanners and not IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements associated with in vitro diagnostics.
In summary, the device is a medical imaging device, specifically a CT scanner, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray computed tomography
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Systems |
| 7-127 Asahigaoka, Hino-shi | |
| 4-chome, Tokyo 191, Japan | |
| Distributor: | GE Medical Systems |
| 3000 N. Grandview | |
| Waukesha, 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)
~~
1
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.