(83 days)
No
The document does not mention AI, ML, or any related terms, and the description focuses on standard CT technology and components.
No
A CT Scanner System is a diagnostic imaging device, not a therapeutic device. It is used to create images for diagnosis, not to treat diseases or conditions.
Yes
The device is a CT scanner, which is used to produce images of the body's internal structures. These images are then interpreted by medical professionals to diagnose various conditions.
No
The device description explicitly states it consists of hardware components such as 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 x-ray computed tomography applications." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details components like a gantry, patient table, console, and computer, which are typical of a CT scanner used for imaging patients directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device is used for in vivo imaging.
N/A
Intended Use / Indications for Use
The HiSpeed QX/i CT Scanner System is indicated for head and whole body x-ray computed tomography applications.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The HiSpeed QX/i CT Scanner System consists 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a stylized circular frame. The letters and the frame are solid black, contrasting with the white background.
APR 1 3 1998
GE Medical Systems
510(k) 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)
Larry A. Kroger, Ph.D. Submitter: Regulatory Programs Manager Who may be contacted by telephone at 414-544-3894 or by FAX at 414-544-3863. Summary prepared 6 January 1998
Product Identification
Name: HiSpeed QX/i CT Scanner System Classification Name: Computed Tomography X-ray System
Manufacturer: General Electric Medical Systems 16800 W. Pyerson Road New Berlin, WI 53151
Same as Manufacturer Distributor:
Marketed Devices:
The HiSpeed HiSpeed QX/i CT Scanner System 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 HiSpeed QX/i CT Scanner System consists of a gantry, patient table, console, computer and associated accessories.
Materials: Materials and construction are equivalent to the HiSpeed CT /i (K940606) and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.
Design: The System is designed to be a head and whole body CT scanner utilizing a solid state detector, and an intuitive Operator Console with the same tube and similar features to the HiSpeed CT/i with WarpScan and Performix Tube Options (K964746).
Indications for Use:
The HiSpeed QX/i CT Scanner System is indicated for head and whole body x-ray computed tomography applications.
1
Comparison with Predicate:
It is the opinion of GE Medical Systems that the HiSpeed QX/i CT Scanner System 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. It will comply with the x-ray requirements of 21 CFR as well as the safety requirements of UL 187, IEC 601-1 and collateral standards.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a hazard analysis and controlled by:
- System verification and validation to insure performance to specifications, Federal . Regulations, and user requirements.
- Adherence to Industry and International Standards. (UL and IEC) .
Conclusions:
Use of the HiSpeed QX/i CT Scanner System does not result in any new potential safety risks and performs as well as or better than devices currently on the market.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/4 description: The image shows a date, "APR 1 3 1998". The month is April, the day is the 13th, and the year is 1998. The text is in a bold, sans-serif font. The text is black against a white background.
Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K980176 HiSpeed OX/i, CT Scanner System Dated: January 12, 1998 Received: January 13, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the easetment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, issing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro disgnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmamain.html".
Sincerely yours,
William Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: HiSpeed QX/i CT Scanner System
Indications For Use:
The HiSpeed QX/i CT Scanner System is intended for head and whole body x-ray computed tomography applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The Counter Use_
David C. Ayres
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number