(54 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The device is an imaging system used for diagnostic purposes by producing images, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states it's for "x-ray computed tomography applications," which is a diagnostic imaging technique used to visualize internal body structures for diagnosis.
No
The device description explicitly lists hardware components such as a gantry, patient support, operator console, and computer, indicating it is a physical medical device system, not software-only.
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 system used to visualize internal structures of the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The components listed (gantry, patient support, operator console, computer, accessories) are typical of an imaging system, not an IVD device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This CT system is used to create images of the body itself.
N/A
Intended Use / Indications for Use
The CT/e Computed Tomography 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 CT/e Computed Tomography system consist of a gantry, patient support, operator console, computer and associated accessories.
Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169)
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 similar features to the HiSpeed LX/i, FX/i and DX/i (K980169).
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.
Not Found
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
DEC 2 | 1999
Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K993645". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters having distinct features.
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are four decorative teardrop shapes placed symmetrically around the circle's perimeter. The logo is presented in black and white.
GE Medical Systems
P.O. Box 414 Milwaukee, WI 53201
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)
- Submitter: Larry A. Kroger Senior Regulatory Programs Manager who may be contacted at 414-544-3894 or FAX 414-544-3863 Summary prepared May 11, 1999 CT/e Computed Tomography scanner system Device Name:
| Device Name: | CT/e Computed Tomography scanner system. |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Manufacturer | GE-YMS |
| 7-127 Asahigaoka 4-Chome | |
| Hino-Shi, Tokyo, Japan 191 | |
| Distributor | General Electric Medical Systems |
| 3000 North Grandview Blvd. | |
| Waukesha, WI 53188 |
Marketed Devices:
The CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed computed tomography systems that comply with the same or equivalent standards and have the same intended uses.
Device Description:
The CT/e Computed Tomography system consist of a gantry, patient support, operator console, computer and associated accessories.
Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169)
1
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 similar features to the HiSpeed LX/i, FX/i and DX/i (K980169).
Indications for Use:
CT/e Computed Tomography system is indicated for head and whole body x-ray computed tomography applications.
Comparison with Predicate Device:
It is the opinion of GE Medical Systems that the CT/e Computed Tomography system is of 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 performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards.
Adverse Effects on Health:
Potential electrical, mechanical, fire and radiation hazards are identified in the attached Risk Analysis and controlled by:
- System verification and validation to insure performance to . specifications, regulatory requirements and user requirements.
- Adherence to Industry and International Standards (UL/IEC/CSA) ●
Conclusions:
Use of the CT/e Computed Tomography 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DFC 21 1999
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems. Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K993645 CT/e Computed Tomography System Dated: October 25, 1999 Received: October 28, 1999 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Dr. 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment 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). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 531 through 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 diagnostic 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 notfication"(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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel S. Schultz, M.D.
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CT/e Computed Tomography system
Indications For Use:
The CT/e Computed Tomography 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)
Daniel G. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use