(13 days)
No
The summary describes a standard CT scanner with image acquisition and reconstruction software, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a CT scanner, which is used for diagnostic imaging, not for treating diseases or conditions.
Yes
CT scanners are used to create detailed images of the body, which are then interpreted by a healthcare professional to diagnose medical conditions.
No
The device description explicitly states it is composed of hardware components (gantry, patient table, console, PDU) 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 is for "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 of the body to diagnose diseases or conditions.
- Device Description: The description details components of a CT scanner (gantry, table, console, etc.) and software for image acquisition and reconstruction. This aligns with the description of an imaging system, not an IVD.
- Input Imaging Modality: The input is "X-ray Computed Tomography," which is an in-vivo imaging technique. IVDs work with in-vitro samples.
IVDs are specifically designed to perform tests on biological specimens in vitro (outside of the living organism) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the living organism) to create images.
N/A
Intended Use / Indications for Use
The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Product codes
90-JAK
Device Description
The LightSpeed 7.0 CT Scanner System is composed of a gantry, patient table, console, and PDU, and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 7.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use.
Materials and construction are equivalent to the LightSpeed 5.0 CT Scanner System, which are compliant with UL 2601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Mentions image processing
Yes
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)
Reference Device(s)
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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" inside a stylized circle. The letters are white, and the circle is black. The logo is simple and recognizable.
MAR - 1. 2004
Image /page/0/Picture/3 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K040372'. The characters are written in a simple, slightly rough style, giving them a casual appearance. The image is in black and white.
GE Medical Systems
3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188
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).
John W. Jaeckle Submitter: Lead CT Safety and Regulatory Engineer Tel: 262-312-7358, Fax: 262-312-7369 e-mail: John.Jaeckle@med.ge.com Date Prepared: February 3, 2003
PRODUCT IDENTIFICATION
| Name: | LightSpeed 7.0 CT Scanner System |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| 21CFR892.1750, 90-JAK | |
| Manufacturer: | General Electric Medical Systems |
| 3000 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Distributor: | Same as Manufacturer |
| Marketed Devices: | The LightSpeed 7.0 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, such as the previous | |
| LightSpeed CT Scanners |
DEVICE DESCRIPTION
The LightSpeed 7.0 CT Scanner System is composed of a gantry, patient table, console, and PDU, and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 7.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use.
Materials and construction are equivalent to the LightSpeed 5.0 CT Scanner System, which are compliant with UL 2601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.
1
Indications for Use:
The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Comparison with Predicate:
LightSpeed 7.0 is a modification of the LightSpeed 5.0 CT Scanner System and has identical indications for use. It has the same technological characteristics and operating principles, is indications for active the came to the towns and QA features, and uses the same basic design, construction, and materials.
In the opinion of GE Medical Systems, the LightSpeed 7.0 CT Scanner System is of in the opinion of GE Mouled Systems, includent to currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended uses. LightSpeed 7.0 will be certified to comply with the X-ray requirements the same intentional accorded as the safety requirements of UL2601-1, and IEC 60601-1 and associated collateral and particular 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 . Regulations, and user requirements.
- Adherence to industry and international standards. (UL/CSA and IEC). .
CONCLUSIONS
The LightSpeed 7.0 CT Scanner System, as an evolutionary modification to the currently rno EightSpeed 5.0, 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 7.0 CT System as or botter that 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 U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes resembling human figures or birds in flight, arranged in a vertical stack.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1. 2004
GE Medical Systems % Mr. Juergen Welte Program Manager 510(k) TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566
Re: K040372 Trade/Device Name: LightSpeed 7.0 CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 10, 2004 Received: February 17, 2004
Dear Mr. Welte:
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 such 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 (OS) 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
STATEMENT OF INTENDED USE
510(k) Number (if known): K040372
Device Name: LightSpeed 7.0 CT Scanner System
Indications For Use:
The LightSpeed 7.0 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
Nancy C. Brogdon
Division Star Division of Renroductive. and Radiological Device 510(k) Number