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.

AI/ML Overview

The provided text is a 510(k) summary for the GE Healthcare LightSpeed 7.1 CT Scanner System. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, the typical information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this type of submission.

Here's a breakdown of why this information is missing and what the document does address:

Type of Device: The LightSpeed 7.1 CT Scanner System is a hardware Computed Tomography (CT) scanner with software modifications. It is not an AI algorithm or a diagnostic assay where performance metrics like sensitivity, specificity, or AUC would be paramount.
Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. The primary goal is to show that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Focus of the Document: The document emphasizes:
- The LightSpeed 7.1 is an "evolutionary modification" of the LightSpeed 7.0 system (K040372).
- Changes involve "new application features that involve changes in software, firmware, recon and scan mode."
- It uses "the same materials and operating principle" as the predicate.
- It has "identical indications for use" (head and whole body X-ray Computed Tomography applications).
- It complies with the same electrical, radiation, and safety standards (e.g., UL 60601-1, IEC 60601-1, 21CFR1020.30, 1020.33).
- Risk management (hazard analysis) was performed, and controls are in place.
- "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" is mentioned, but specific performance criteria and the study results demonstrating adherence to them are not detailed in this public summary. These would typically be internal GE documentation used to support the substantial equivalence claim, rather than being part of the 510(k) summary itself.

In summary, none of the specific "acceptance criteria" or "study details" you requested for performance evaluation of a diagnostic or AI device are present in this 510(k) summary because it's a submission for an updated CT scanner, focusing on substantial equivalence to a predicate, not novel performance claims.

Summary

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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.

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DEVICE DESCRIPTION

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.

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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.

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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

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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

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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

Page 1 of 1

(32

Regulation Number and Section

§ 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.