GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

{0}------------------------------------------------ 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-706<br>Waukesha, WI 53188 | | Contact: | Steven Kachelmeyer<br>Pre-Market Regulatory Affairs Program Manager<br>Tel: 262-548-2432, Fax: 262-997-1080<br>e-mail: steven.kachelmeyer@med.ge.com | | Date Prepared: | July 18, 2008 | | PRODUCT IDENTIFICATION | | | Name:<br>(Scanner System) | GE LightSpeed RT16 / LightSpeed Xtra V2<br>(Also known as LightSpeed RT16 /LightSpeed Xtra CT) | | Classification Name: | Computed Tomography X-ray System<br>21CFR892.1750, 90-JAK | | Manufacturer: | GE Hangwei Medical Systems Co. Ltd.<br>No 1 Young Change North Rd<br>Beijing Economic and Technology Development Zone<br>Beijing, China 100176 | | | Future Production may also be accomplished at one of our<br>other registered CT Manufacturing facilities. | | Distributor: | Same as Manufacturer | | Marketed Devices: | The GE LightSpeed RT16 / LightSpeed Xtra V2<br>(aka LightSpeed RT16 /LightSpeed Xtra CT) is of comparable<br>type and substantially equivalent to GE's currently marketed<br>Computed Tomography X-ray Systems that comply with the<br>same or equivalent standards and have similar intended<br>uses, such as the previous LightSpeed Xtra CT Scanner. | {1}------------------------------------------------ #### Predicate Device(s): GE LightSpeed Xtra CT Scanner System (K060052) # 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. #### 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. 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 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. 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). {2}------------------------------------------------ # 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. {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ # 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 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. 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