(14 days)
K00372,K040372
No
The document describes standard CT scanner components and software for image acquisition and reconstruction, with no mention of AI, ML, or related concepts.
No
This device is a CT scanner, which is an imaging device used for diagnosis, not a therapeutic device used for treatment.
Yes
The device is a CT scanner used for X-ray Computed Tomography applications of the head and whole body, which is a diagnostic imaging modality.
No
The device description explicitly states it is composed of hardware components (gantry, patient table, operator console, computer, PDU, image acquisition hardware) in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "head and whole body Xray 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, tissue, etc.) outside of the body.
- Device Description: The description details the components of a CT scanner (gantry, table, console, etc.) and its function in acquiring and reconstructing images from X-ray data. This aligns with the function of an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This CT scanner is used to directly image the body.
N/A
Intended Use / Indications for Use
The LightSpeed 7.1 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Product codes
JAK
Device Description
The LightSpeed 7.1 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The LightSpeed 7.1 Scanner System is an evolutionary modification to LightSpeed 7.0 (K00372) It is developed from the hardware platform of LightSpeed 7.0 32/64 slice system by adding new application features that involve changes in software, firmware, recon and scan mode.
The LightSpeed 7.1 Scanner System 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 our existing marketed products, which are compliant with UL 60601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR 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)
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
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
JUL 1 2 2006
R661817
GE Healthcare
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).
Submitter: John Jaeckle Regulatory Affairs Program Manager- MI & CT Tel: 262-312-7358, Fax: 262-312-7369 e-mail: John.Jaeckle@med.ge.com Date Prepared: June 13, 2006
PRODUCT IDENTIFICATION
Name:
LightSpeed 7.1 CT Scanner System
- Classification Name: Computed Tomography X-ray System 21CFR892.1750, 90-JAK
GE Medical Systems LLC (GE Healthcare) Manufacturer: 3000 N. Grandview Blvd. Waukesha, WI 53188
GE YOKOGAWA MEDICAL SYSTEMS 7-127 Asahigaoka 4-chome Hino-shi, Tokyo, JAPAN 191
Distributor:
Same as Manufacturer
Marketed Devices: The LightSpeed 7.1 CT Scanner System is of comparable type and substantially equivalent to GE's 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.
1
DEVICE DESCRIPTION
The LightSpeed 7.1 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The LightSpeed 7.1 Scanner System is an evolutionary modification to LightSpeed 7.0 (K00372) It is developed from the hardware platform of LightSpeed 7.0 32/64 slice system by adding new application features that involve changes in software, firmware, recon and scan mode.
The LightSpeed 7.1 Scanner System 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 our existing marketed products, which are compliant with UL 60601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Indications for Use:
The LightSpeed 7.1 Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Comparison with Predicate:
The LightSpeed 7.1 Scanner System is developed from the hardware platform of our LightSpeed 7.0 32/64 slice system (K040372). The LightSpeed 7.1 involves changes from the LightSpeed 7.0 system to add new application features that involve changes in application software, firmware, recon and scan mode. The LightSpeed 7.1 Scanner System uses the same materials and operating principle as our existing marketed product, LightSpeed 7.0, as well as having identical indications for use. We believe the LightSpeed 7.1 Scanner System is of comparable type and substantially equivalent to currently marketed system listed above and complies with the same or equivalent standards and have the same intended uses.
LightSpeed 7.1 Scanner System will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL 60601-1, 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 and certification to industry and international standards. (UL/CSA and IEC). .
- Compliance to applicable CDRH 21CFR subchapter J requirements. .
The device is designed and manufactured under the Quality System Regulations of 21CFR820.
2
CONCLUSIONS
The LightSpeed 7.1 CT Scanner System is developed from the hardware platform of our LightSpeed 7.0 32/64 slice system (K040372) and 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 7.1 CT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.
3
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 2 2006
GE Medical Systems LLC (GE Healthcare) % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K061817
Trade/Device Name: LightSpeed 7.1 CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 27, 2006 Received: June 28, 2006
Dear Mr. Devine:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" in the middle. The letters "FDA" are prominently displayed in the center of the logo. Three stars are arranged in a horizontal line below the word "Centennial". The text around the circle is difficult to read due to the image quality.
Protecting and Promoting Public Health
4
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
5
Indications for Use
510(k) Number (if known):
Device Name:
LightSpeed 7.1 CT Scanner System
Indications For Use: The LightSpeed 7.1 CT Scanner System is indicated for head and whole body Xray Computed Tomography applications.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BEL.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ingram
(Division Sian-Division of I and Radiolor 510(k) Num
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