The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16/ LightSpeed Xtra) 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), 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 RT18 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT18/ LightSpeed Xtra) is indicated for head, whole body, 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.

The system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40).

When used in the LightSpeed RT16 configuration, the system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

Device Description

The GE LightSpeed RT16 / LightSpeed Xtra V2 (aka LightSpeed RT16 /LightSpeed Xtra CT) CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.5 seconds (at full) per rotation, and can acquire up to 16 slices of data per rotation with a maximum total coverage of 20mm in the axial direction. The system can be operated in Axial, Cine, Helical, Fluoro and Gated acquisition modes.

The GE LightSpeed RT16 / LightSpeed Xtra V2 CT 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) summary describes a GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System. The submission focuses on substantial equivalence to a predicate device and safety considerations rather than demonstrating performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided text.

Specifically:

No detailed acceptance criteria with performance metrics are provided. The document outlines the device's technical specifications and intended use but does not list specific quantitative performance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) that a study would then prove the device meets.
No specific study is described that tests the device's diagnostic performance against established acceptance criteria. The document mentions "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" and "Adherence and certification to industry and international standards." However, these refer to engineering and regulatory compliance, not a clinical study demonstrating diagnostic effectiveness.

Therefore, the following points will indicate that the information is "Not Available in the provided text" where the document does not contain the answer.

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

Acceptance Criteria	Reported Device Performance
Not Available in the provided text	Not Available in the provided text

Explanation: The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report specific performance metrics for the device against such criteria. It emphasizes substantial equivalence to a predicate device and compliance with safety and regulatory standards.

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

Sample Size: Not Available in the provided text
Data Provenance: Not Available in the provided text

Explanation: As no study demonstrating diagnostic performance is described, information on sample size and data provenance for a test set is not provided.

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

Number of Experts: Not Available in the provided text
Qualifications of Experts: Not Available in the provided text

Explanation: Without a described study involving ground truth establishment, this information is not available.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not Available in the provided text

Explanation: This information is not available as no study involving expert adjudication is described.

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

MRMC Study Done: No.
Effect Size: Not Applicable.

Explanation: The document describes a CT scanner system, not an AI-powered diagnostic device or a system designed to assist human readers in a diagnostic task that would typically involve an MRMC study assessing AI assistance.

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

Standalone Performance Study Done: No.

Explanation: This device is a CT scanner, an imaging modality, not an algorithm, so a standalone algorithm performance study is not applicable in the context described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not Available in the provided text

Explanation: No study requiring the establishment of diagnostic ground truth is described.

8. The sample size for the training set:

Sample Size: Not Available in the provided text

Explanation: As this is primarily a hardware submission for a CT scanner system, and not an AI/algorithm-focused submission, there is no mention of a training set.

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

Ground Truth Establishment: Not Available in the provided text

Explanation: No training set is mentioned in the document.

Summary of the Document's Approach:

The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (GE LightSpeed Xtra CT Scanner System K060052) and compliance with regulatory and safety standards for the manufacturing and operation of the CT scanner. It highlights:

The new device is an "evolutionary modification" to an existing platform.
It shares "virtually the same materials and identical operating principle" as the predicate.
It has "similar indications for use."
It complies with X-ray requirements (21CFR1020.30 and 1020.33) and safety standards (UL 60601-1, IEC 60601-1).
Risk management and verification/validation ensure performance to specifications and user requirements.

This type of submission typically does not involve new clinical studies to establish diagnostic accuracy against specific human-interpretable acceptance criteria, but rather demonstrates that the updated device performs equivalently and safely to its predicate.

Summary

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Image /page/0/Picture/1 description: The image contains a handwritten number, which appears to be "1082104". The numbers are written in a simple, slightly slanted style. The digits are clearly distinguishable, although the writing has a casual, informal quality.

GE Healthcare

3000 N. Grandview Blvd. W-706 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:	GE Medical Systems, LLC (GE Healthcare)
Address:	3000 N. Grandview Blvd., W-706Waukesha, WI 53188
Contact:	Steven KachelmeyerPre-Market Regulatory Affairs Program ManagerTel: 262-548-2432, Fax: 262-997-1080e-mail: steven.kachelmeyer@med.ge.com
Date Prepared:	July 18, 2008
PRODUCT IDENTIFICATION
Name:(Scanner System)	GE LightSpeed RT16 / LightSpeed Xtra V2(Also known as LightSpeed RT16 /LightSpeed Xtra CT)
Classification Name:	Computed Tomography X-ray System21CFR892.1750, 90-JAK
Manufacturer:	GE Hangwei Medical Systems Co. Ltd.No 1 Young Change North RdBeijing Economic and Technology Development ZoneBeijing, China 100176
	Future Production may also be accomplished at one of ourother registered CT Manufacturing facilities.
Distributor:	Same as Manufacturer
Marketed Devices:	The GE LightSpeed RT16 / LightSpeed Xtra V2(aka LightSpeed RT16 /LightSpeed Xtra CT) is of comparabletype and substantially equivalent to GE's currently marketedComputed Tomography X-ray Systems that comply with thesame or equivalent standards and have similar intendeduses, such as the previous LightSpeed Xtra CT Scanner.

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Predicate Device(s):

GE LightSpeed Xtra CT Scanner System (K060052)

DEVICE DESCRIPTION

Indications for Use:

The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16 / LightSpeed Xtra) 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), 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 RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16 / LightSpeed Xtra) is indicated for head, whole body, and rascular 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 RT16 / LightSpeed Xtra V2 CT Scanner System is developed from the hardware platform of our LightSpeed Xtra system (K060052). The GE LightSpeed RT16 / LightSpeed Xtra V2 involves changes from the LightSpeed Xtra system to add new application features that involve changes in hardware, application software, and firmware. The GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System uses virtually the same materials and identical operating principle as our existing marketed product, LightSpeed Xtra, as well as having similar indications for use. We believe the GE LightSpeed RT16 / LightSpeed Xtra V2 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 RT16 / LightSpeed Xtra V2 CT Scanner System will be certified to comply with the X-ray requirements 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 RT16 / LightSpeed Xtra V2 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 market. The GE LightSpeed RT16 / LightSpeed Xtra V2 CT system will be certified to comply with the X-ray requirements of 21CFR 1020.30 and 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 RT16 / LightSpeed Xtra V2 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems, LLC (GE Healthcare) % Mr. Daniel W. Lehtonen Senior Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K082104

Trade/Device Name: GE LightSpeed RT16 / LightSpeed Xtra V2 (aka GE LightSpeed RT16 / LightSpeed Xtra) CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 20, 2008 Received: August 21, 2008

SEP - 2 2008

Dear Mr. Lehtonen:

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 Compliarice prome 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 contect 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 ma wobtain 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/cdrf/industry/support/index.html .

Sincerely yours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Indications for Use

510(k) Number (if known):

K082104

Device Name: GE LightSpeed Xtra V2 (aka GE LightSpeed RT16 / LightSpeed RT16 / LightSpeed Xtra) CT Scanner System

Indications for Use:

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

When used in the LightSpeed RT16 configuration, the system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Halus lemm

n of Reproductive, Abdominal a Radiological Devices 510(k) Number

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.