(13 days)
Not Found
No
The summary describes a hardware upgrade to a CT scanner with a new detector and increased slice capability, but makes no mention of AI or ML in the device description, intended use, or performance studies.
No.
The LightSpeed 4.0 CT Scanner System is indicated for diagnostic imaging (head and whole body X-ray Computed Tomography applications), not for treating conditions or diseases.
Yes
A CT scanner is a diagnostic device used to obtain images of the body's internal structures, which are then interpreted by medical professionals to diagnose various conditions. The "Intended Use / Indications for Use" section explicitly states "X-ray Computed Tomography applications," which inherently involves diagnosis.
No
The device description explicitly lists hardware components such as a gantry, patient table, console, and computer, indicating it is a physical medical device system, not software-only.
No, 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.
- Device Description: The description details components like a gantry, patient table, console, and computer, which are typical of a CT scanner. It also mentions a "solid state detector" and "multi-slice detector," further confirming its function as an imaging device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any sample collection, analysis of biological samples, or diagnostic testing performed on such samples.
The LightSpeed 4.0 CT Scanner System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Cor Tomography applications.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The LightSpeed 4.0 CT Scanner System is composed of a gantry, patient table, console, computer, and associated accessories.
Materials: Materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978) are compliant with UL 2601-1, IEC 60061-1, and 21CFR Subchapter J.
Design: The system is designed to be a head and whole body CT scanner utilizing a new solid state detector, an intuitive Operator Console, and the same tube and similar features to the LightSpeed 3.0 CT Scanner System (K002978), but now capable of imaging 16 slices per rotation. The system will use a new multi-slice detector having thinner detector elements.
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
NOV 0 82001
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and the border are solid black, contrasting with the white background. The logo is simple and iconic, representing the well-known multinational conglomerate.
GE Medical Systems
General Electric Compa
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
Larry A. Kroger, Ph.D. Submitter: Senior Regulatory Programs Manager TEL: 262-544-3894, FAX: 262-544-3863 Summary prepared: October 15, 2001
PRODUCT IDENTIFICATION
| Name: | LightSpeed 4.0 CT Scanner System |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Manufacturer: | General Electric Medical Systems |
| 16800 W. Ryerson Road | |
| New Berlin, WI 53151 | |
| Distributor: | Same as Manufacturer |
| Marketed Devices: | The LightSpeed 4.0 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 LightSpeed 4.0 CT Scanner System is composed of a gantry, patient table, console, computer, and associated accessories.
Materials: Materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978) are compliant with UL 2601-1, IEC 60061-1, and 21CFR Subchapter J.
Design: The system is designed to be a head and whole body CT scanner utilizing a new solid state detector, an intuitive Operator Console, and the same tube and similar features to the LightSpeed 3.0 CT Scanner System (K002978), but now capable of imaging 16 slices per rotation. The system will use a new multi-slice detector having thinner detector elements.
1
Indications for Use:
The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Cor Tomography applications.
Comparison with Predicate:
It is the opinion of GE Medical Systems that the LightSpeed 4.0 CT Scanner System is of a 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 21CFR1020.30 and1020.33, as well as the safety requirements of UL2601-1, IEC 60601-1 and collateral standards.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analysis) and controlled by:
- System verification and validation to ensure performance to specifications, Federal . Requlations, and user requirements.
- Adherence to industry and international standards. (UL/CSA and IEC). .
CONCLUSIONS
The LightSpeed 4.0 CT Scanner Systems does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the LightSpeed 4.0 CT System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare. The caduceus is depicted with three lines representing the snakes entwined around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
General Electric Medical Systems % Mr. Reiner Krumme Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K013561
Trade/Device Name: LightSpeed 4.0 CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 22, 2001 Received: October 26, 2001
Dear Mr. Krumme:
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 for do bear of 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 I ou may , ators, and second 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.
3
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 11 you 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
4
NOV 0 8 2001
STATEMENT OF INTENDED USE
510(k) Number (if known): __ Kor 356 /
Device Name: LightSpeed 4.0 CT Scanner System
Indications For Use:
The LightSpeed 4 CT Scanner 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 Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013561