(16 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description focuses on standard CT scanner components and safety standards.
No.
The device is indicated for X-ray computed tomography applications, which is a diagnostic imaging procedure, not a therapeutic one. It is used to acquire images for diagnosis, not to treat a disease or condition.
Yes.
The device's intended use is for X-ray computed tomography applications, which is a diagnostic imaging technique used to visualize internal body structures for medical diagnosis.
No
The device description explicitly states it is composed of hardware components such as a gantry, patient table, and image acquisition hardware, 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 lists components typical of a CT scanner (gantry, patient table, console, etc.). These are all external components used for acquiring images of the patient directly.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any processes related to in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. This device is an in vivo imaging device.
N/A
Retracted - Please Regenerate From Source Text
Intended Use / Indications for Use
The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.
Product codes
90 JAK
Device Description
The GE LightSpeed Ultra CT Scanner System with Wide - View is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Ultra CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
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 device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
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
Ko2 3332
Special 510(k) Premarket Notification GE Medical Systems - LightSpeed Ultra CT System with Wide - View option October 3, 2002
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.
OCT 2 3 2002 GE Medical Systems
P.O. Box 414. W-1140 Milwaukee, WI 53201
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Senior Regulatory Programs Manager
Telephone: 262-544-3894; Fax: 262-548-4768 |
| Date Prepared: | October 2, 2002 |
| Device Name: | LightSpeed Ultra Computed Tomography System with Wide - View.
Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK |
| Marketed Device: | GE Medical System's LightSpeed Ultra Computed Tomography System
510(k) Number K000300, currently in commercial distribution. |
Device Description:
The GE LightSpeed Ultra CT Scanner System with Wide - View is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Ultra CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
Indications for Use:
The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.
Comparison with Predicate Device:
The GE LightSpeed Ultra Computed Tomography System with Wide - View is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed Ultra CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.
Summary of Studies:
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
Conclusion:
Intended use and fundamental scientific technology are the same as the legally marketed GE LightSpeed Ultra CT System. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the LightSpeed Ultra CT System with Wide - View is substantially equivalent to the currently cleared LightSpeed Ultra CT System.
1
Food and Drug Administration 200 Corporate Boulevard Rockville MD. 20850
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-1140 MILWAUKEE WI 53201
Re: K023332
Trade/Device Name: LightSpeed Ultra CT Scanner with Wide-View Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
Regulatory Class: II Product Code: 90 JAK Dated: October 3, 2002 Received: October 7, 2002
Dear Dr. Kroger:
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, Drug, 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.
Image /page/1/Picture/12 description: The image shows a partial view of a seal or emblem. The visible portion includes stylized lettering arranged vertically, spelling out "DEPARTMUT OF HEALTH". The text curves along the edge of the emblem, and a portion of a graphic element is visible to the right of the text.
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 vours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
al 510(k) Premarket Notification GE Medical Systems - LightSpeed Ultra CT System with Wide - View option October 3. 2002
STATEMENT OF INTENDED USE
510(k) Number (if known): ______________________________________________________________________________________________
Device Name: LightSpeed Ultra CT System with Wide - View
Indications for Use
The LightSpeed Ultra CT Scanner System with Wide - View 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_
Nancy C hogdon
510k) N E-2