(45 days)
No
The summary describes standard CT imaging and reconstruction techniques, including "real time" reconstruction and automated triggering based on contrast enhancement, but does not mention any AI or ML algorithms.
No.
The device is described as an x-ray computed tomography system intended for diagnostic imaging, not for treating diseases or conditions.
Yes
This device is an x-ray computed tomography (CT) system, which is a diagnostic imaging modality used to create detailed images of the inside of the body. The "Intended Use / Indications for Use" section explicitly states its purpose for "head and whole body x-ray computed tomography applications," which are inherently diagnostic in nature.
No
The device description explicitly states that the ProSpeed Family of Systems consists of hardware components including a gantry, patient table, console, computer, and associated accessories. The options described are modifications to this existing hardware platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "head and whole body x-ray computed tomography applications." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details a "x-ray computed tomography scanner" consisting of a gantry, patient table, console, computer, and accessories. This is consistent with an imaging system.
- Principals of Operation: It states the principals of operation are the same as a previous CT scanner.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
The device is clearly an in vivo diagnostic imaging device, specifically a CT scanner, used to acquire images of the inside of the body.
N/A
Intended Use / Indications for Use
The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans.
Fluoro Scan Option is an almost "real time" reconstruction (Smart Recon) with a display latency of 0.8 to 1.6 seconds. An in-room monitor provides an image display with either a 3 frame/sec or 6 frame/sec display of 90 one second rotation scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
SmartPrep Option is a tool to aid in triggering a helical or axial series of scans after contrast is injected. It allows the operator to monitor contrast as it enhances. A series of images, acquired immediately after injection, is automatically displayed along with pre-selected regions of interest. A graph plots the increase in CT numbers. When the region of interest begins approaching peak enhancement the operator can see that happen on the graph and initiate the CT series.
Product codes
Not Found
Device Description
The ProSpeed Family of Systems are x-ray computed tomography scanners based on the ProSpeed Plus platform 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, IEC 601-1, and 21 CFR Subchapter J.
Design: The design is essentially the same as the CT ProSpeed with Hillight detector (K944013) the difference being that the Fluoro Scan option includes an in-room monitor and a control pedestal. The control pedestal allows for gantry tilt and table positioning as well as initiation and termination of scanning.
Energy Source and Exposure Levels: The energy source and exposure levels are the same as those previously submitted for ProSpeed with HiLight Detector.
Principals of Operation: The same as ProSpeed with HiLight Detector.
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
physician or their assistant during procedures that require imaging / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 font, enclosed within a circular frame. The letters and the frame are black, and the background is white. There are decorative swirls around the letters within the circle.
APR - 4 1997
GE Medical Systems
Generai Electric Company P.O Box 414, Milwaukee, WI 53201
Summary of Safety & Effectiveness
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
Submitter. Larry A. Kroger, Ph.D.
Regulatory Programs Manager Who may be contacted by telephone at 414-544-3894 or by FAX at 414-544-3863. Summary prepared 14 February 1997
Product Identification
Name: CT ProSpeed Family of CT Systems with ProSpeed Remaissance Options
| Manufacturer: | GE-YMS
7-127 Asahigaoka 4-Chome
Hino-Shi, Tokyo, Japan 191 |
|---------------|------------------------------------------------------------------|
| Distributor: | GE Medical Systems
3000 Grandview
Waukesha, Wi 53188 |
Marketed Devices:
The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is of comparable type and substantially equivalent to currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have the same intended uses.
Device Description:
The ProSpeed Family of Systems are x-ray computed tomography scanners based on the ProSpeed Plus platform 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, IEC 601-1, and 21 CFR Subchapter J.
Design: The design is essentially the same as the CT ProSpeed with Hillight detector (K944013) the difference being that the Fluoro Scan option includes an in-room monitor and a control pedestal. The control pedestal allows for gantry tilt and table positioning as well as initiation and termination of scanning.
Energy Source and Exposure Levels: The energy source and exposure levels are the same as those previously submitted for ProSpeed with HiLight Detector.
Principals of Operation: The same as ProSpeed with HiLight Detector.
Image /page/0/Picture/20 description: The image shows a logo for "100 Years of Radiology 1895-1995". The logo is black and white and features a stylized image of an X-ray tube. The text is located below the image of the X-ray tube.
1
Indications for Use:
The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans.
Fluoro Scan Option is an almost "real time" reconstruction (Smart Recon) with a display latency of 0.8 to 1.6 seconds. An in-room monitor provides an image display with either a 3 frame/sec or 6 frame/sec display of 90 one second rotation scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
SmartPrep Option is a tool to aid in triggering a helical or axial series of scans after contrast is injected. It allows the operator to monitor contrast as it enhances. A series of images, acquired immediately after injection, is automatically displayed along with pre-selected regions of interest. A graph plots the increase in CT numbers. When the region of interest begins approaching peak enhancement the operator can see that happen on the graph and initiate the CT series.
Comparison with Predicate:
It is the opinion of GE Medical Systems that the CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is of a comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source, and radiation characteristics.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a hazard analysis and controlled by:
- Fault Tree 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 CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options does not result in any new potential safety risks and performs as well as or better than devices currently on the market.