(87 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is standard for a CT scanner without indicating advanced processing.
No
The device is indicated for x-ray computed tomography applications, which is a diagnostic imaging technique, not a therapeutic one.
Yes
Explanation: The device is an x-ray computed tomography (CT) system, which generates images used by medical professionals to diagnose various conditions in the head and whole body.
No
The device description explicitly lists hardware components such as a gantry, patient table, console, and computer, indicating it is a hardware-based 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 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 (like blood, urine, or tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description lists components like a gantry, patient table, console, and computer, which are typical of imaging systems, 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.
Therefore, this device falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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 LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems consists of a gantry, patient table, console, computer and associated accessories. 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. 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 CT / i (K940606).
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
GE Medical Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------0x 414 11 Marikee NI 5320
APR 1 3 1998
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)
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 24 December 1997
Summary prepared 24 December 1999
Product Identification
Name: HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems Classification Name: Computed Tomography X-ray System
| 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 HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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 LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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 similar features to the HiSpeed CT / i (K940606).
Indications for Use:
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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 LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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:
- . 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 LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create the impression of movement and dynamism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1998
Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems. Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K980169 HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems Dated: January 12, 1998 Received: January 13,1 998 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 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 (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 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 (OS) 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 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 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 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/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D 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: HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems
Indications For Use:
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems are indicated 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 CER 801-109)
Over-The Counter Use_ OR
Yand A. Hymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number