(13 days)
No
The summary does not mention AI, ML, or any related terms, and the device description is standard for a CT system.
No
The device is a Computed Tomography (CT) system, which is used for diagnostic imaging (creating images of the body) rather than directly treating a medical condition.
Yes
The device is used for X-ray Computed Tomography applications of the head and whole body, which is a diagnostic imaging technique to detect diseases and injuries.
No
The device description explicitly lists hardware components such as a gantry, patient support, operator console, and computer, indicating it is a physical system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description clearly states the device is a "Computed Tomography System" that uses "X-ray Computed Tomography" for "head and whole body X-ray Computed Tomography applications." This involves imaging the inside of the body using X-rays, not analyzing samples taken from the body.
The information provided describes a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Hispeed CT/e Dual 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 Hispeed CT/e Dual Computed Tomography system consist of a gantry, patient support, operator console ,computer and associated accessories.
Materials: All construction and materials are complaint with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to CT/e (K993645)
Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an intutive Operator Console with similar features to the CT/e (K993645)
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)
The document states "Use of the Hispeed CT/e Dual Computed Tomography system do not result in any new potential safety risks and performs as well as, or better than devices currently on the market." without providing specific study details.
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.
Not Found
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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. There are three decorative swirls or flourishes placed around the circle, spaced evenly apart. The logo is black and white.
Image /page/0/Picture/2 description: The image shows a handwritten sequence of numbers and letters. The sequence appears to be 'K021491'. The handwriting is somewhat rough, with varying stroke thicknesses, giving it a casual, informal appearance. The numbers and letters are clearly distinguishable, though the style is not perfectly uniform.
GE Medical Systems
P.O. Box 414 Milwaukee, WI 53201
March 15, 2002
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21CFR 807.87 (h)
Submitter: Larry A. Kroger
Senior Regulatory Programs Manager
who mav be contacted at (414) 544-3894 or by FAX (414) 544-3863
Summary prepared March 15, 2002
Device Name :Hispeed CT/e Dual Computed Tomography system.
Classification Name : Computed Tomography X-ray system
Manufacturer: GE Hangwei Medical Systems Co. Ltd.
No.2, North Yong Chang Street
Beijing Economic Technological Development Zone
Beijing 100176, P.R.China
Distributor: General Electric Medical Systems 3000 North Grandview Blvd
Waukesha, WI 53188
Marketed Device:
The Hispeed CT/e Dual 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.
1
Device Description:
The Hispeed CT/e Dual Computed Tomography system consist of a gantry, patient support, operator console ,computer and associated accessories.
Materials: All construction and materials are complaint with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to CT/e (K993645)
Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an intutive Operator Console with similar features to the CT/e (K993645)
Indications for Use:
The Hispeed CT/e Dual 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 Hangwei Medical systems that the Hispeed CT/e Dual Computed Tomography system is comparable type and substantially equivalent to currently marketed head and whole body X-ray Tomography systems with respect to design,material composition,energy source and radiation characteristics . It will comply requirements of the IEC60601-1 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 Hispeed CT/e Dual Computed Tomography system do not result in any new potential safety risks and performs as well as, or better than devices currently on the market.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard ckville MD 20850
GE Medical Systems, Inc. % Mr. Wolfram Gmelin TUV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470
Re: K021491 Trade/Device Name: HiSpeed CT/e Dual Computed Tomography System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: May 8, 2002 Received: May 9, 2002
Dear Mr. Gmelin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INTENDED USE
510(k) Number (if known): _ Ko21491
Device Name: Hispeed CT/e Dual Computed Tomography System
Indications For Use:
The Hispeed CT/e Dual Computed Tomography System is 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 CFR 801.109) |
-OR-
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproduction Abdominal |
Division of Reproductive and Radiological Device 510(k) Number _