The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed CT750 HD CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

Device Description

The GE LightSpeed CT750 HD CT Scanner System (aka LightSpeed 8.0) 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 GE LightSpeed CT750 HD Scanner System is an evolutionary modification to LightSpeed 7.1 (K061817). It is developed from the hardware platform of LightSpeed 7.1 32/64 slice system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE LightSpeed CT750 HD Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

AI/ML Overview

This 510(k) premarket notification is for the GE LightSpeed CT750 HD CT Scanner, which is a Computed Tomography X-ray System. The submission claims substantial equivalence to the GE LightSpeed 7.1 CT Scanner System (K061817).

1. Table of acceptance criteria and the reported device performance:

The document focuses on substantiating equivalence rather than defining and meeting specific analytical performance acceptance criteria for an AI/CAD system. The acceptance criteria for the GE LightSpeed CT750 HD are implicitly based on demonstrating that it performs as well as or better than the predicate device (GE LightSpeed 7.1) and adheres to relevant safety and regulatory standards.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Compliance with X-ray performance standards: 21CFR1020.30 and 1020.33. Compliance with electrical and medical device safety standards: UL 60601-1, IEC 60601-1 and associated collateral and particular standards. Potential electrical, mechanical, and radiation hazards identified and controlled through risk management. Manufactured under Quality System Regulations (21CFR820).	The GE LightSpeed CT750 HD system is certified to comply with 21CFR1020.30, 1020.33, UL 60601-1, and IEC 60601-1 and associated collateral and particular standards. Hazards are identified and controlled through system verification, validation, and adherence to standards.
Performance/Equivalence	Perform as well as or better than devices currently on the market (specifically, the predicate GE LightSpeed 7.1). Maintain similar indications for use as the predicate device. Incorporates the same basic fundamental operating principles as the predicate device. Materials and construction equivalent to existing marketed products.	The GE LightSpeed CT750 HD is described as an "evolutionary modification" to the LightSpeed 7.1. It performs "as well as or better than devices currently on the market". It has "virtually the same materials and identical operating principle" and "similar indications for use."
Functional Features	Ability to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. Support for Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. Ability to obtain images with or without contrast. Includes signal analysis and display equipment, patient and equipment supports, components and accessories. Ability to perform data and image processing, post-processing for additional imaging planes or analysis. Indicated for head, whole body, cardiac, and vascular X-ray CT applications.	The device's description and indications for use directly match these functional features, confirming its capability to perform these tasks. The spectral imaging option is also described.

2. Sample size used for the test set and the data provenance:

The document does not describe a "test set" in the context of evaluating an AI or CAD algorithm. Instead, it describes modifications to a CT scanner system. Therefore, there is no specific sample size of images or patients for a test set mentioned, nor is there information on data provenance (country of origin, retrospective/prospective). The study focuses on system-level verification and validation against technical specifications and regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no test set requiring expert-established ground truth for an AI/CAD algorithm is described. The evaluation is for a CT scanner system's performance and safety.

4. Adjudication method for the test set:

Not applicable, as no test set requiring adjudication for an AI/CAD algorithm is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for a medical imaging device (CT scanner), not an AI or CAD software intended to assist human readers. Therefore, an MRMC study related to AI assistance is not described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This submission is for a CT scanner, not a standalone AI algorithm.

7. The type of ground truth used:

Not applicable in the context of an AI/CAD algorithm. For the CT scanner system, the "ground truth" implicitly refers to established engineering specifications, performance metrics (e.g., image quality parameters, dose), and compliance with international safety and performance standards. The device's performance is verified and validated against these objective measures.

8. The sample size for the training set:

Not applicable. This submission is for a CT scanner hardware and integrated software system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning model described in this submission.

Summary

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K081105

MAY - 9 2008

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:Name:Address:	GE Medical Systems, LLC (GE Healthcare)3000 N. Grandview Blvd., W-1140Waukesha, WI 53188
Contact:	John JaeckleRegulatory Affairs Program Manager- MI & CTTel: 262-312-7358, Fax: 262-312-7369e-mail: John.Jaeckle@med.ge.com
Date Prepared:	April 8, 2008
PRODUCT IDENTIFICATION
Name:	GE LightSpeed CT750 HD(Also known as LightSpeed 8.0 CT Scanner System)
Classification Name:	Computed Tomography X-ray System21CFR892.1750, 90-JAK
Manufacturer:	GE Medical Systems, LLC (GE Healthcare)3000 N. Grandview Blvd.Waukesha, WI 53188Future Production may also be accomplished at one of ourother registered CT Manufacturing facilities.
Distributor:	Same as Manufacturer
Marketed Devices:	The GE LightSpeed CT750 HD CT Scanner System (akaGE LightSpeed 8.0) is of comparable type and substantiallyequivalent to GE's currently marketed ComputedTomography X-ray Systems that comply with the same orequivalent standards and have similar intended uses, suchas the previous LightSpeed CT Scanners.

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Predicate Device(s):

GE LightSpeed 7.1 CT Scanner System (K061817)

DEVICE DESCRIPTION

Indications for Use:

The GE LightSpeed CT750 HD CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

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Comparison with Predicate:

The GE LightSpeed CT750 HD Scanner System is developed from the hardware platform of our LightSpeed 7.1 32/64 slice system (K061817). The GE LightSpeed CT750 HD involves changes from the LightSpeed 7.1 system to add new application features that involve changes in hardware, application software, firmware, recon, and scan mode as well as introducing a new 64-slice detector. The GE LightSpeed CT750 soun mode as wirtually the same materials and identical operating principle HD Ooanner Cyclom asso virtually LightSpeed 7.1, as well as having similar indications for use. We believe the GE LightSpeed CT750 HD Scanner System is of comparable type and substantially equivalent to our currently marketed system listed above and complies with the same or equivalent standards and have the same intended uses.

The GE LightSpeed CT750 HD Scanner System will be certified to comply with the Xr no of Elghtopod of 21CFR1020.30 and1020.33, 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.

Conclusions:

The GE LightSpeed CT750 HD CT Scanner System is an evolutionary modification to the LightSpeed 7.1 32/64 slice system (K061817). It does not result in any new potential safety risks and performs as well as or better than devices currently on the portunitial career mono and CT750 HD system will be certified to comply with the X-ray mantol. The GE LightSpoor of 1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards. GE considers the GE LightSpeed CT750 HD CT Scanner System to be equivalent to other marketed devices with similar indications for use and meeting similar standards.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

GE Medical Systems, LLC (GE Healthcare) % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K081105

Trade/Device Name: GE LightSpeed CT750 HD CT Scanner (aka LightSpeed 8.0) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 17, 2008 Received: April 18, 2008

Dear Mr. Kogoma:

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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely vours.

NancyCbrogdon

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): K081105

GE LightSpeed CT750 HD CT Scanner System (aka LightSpeed 8.0) Device Name:

Indications for Use:

The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

The GE LightSpeed CT750 HD CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system, the system can acquire CT images using different KV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

Prescription Use	X	AND
(Part 21 CFR 801 Subpart D)

VOR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ige MWhan

Division of Reproductive. Abdominal and Radiological Devices 510(k) Number

Page 1 of 1

4-2

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.