DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9

{0}------------------------------------------------ K073056 Page 1 of 3 # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. | Date: | Aug. 31, 2007 | |-------|---------------| |-------|---------------| **NOV 1 3 2007** 1. Company and Correspondent making the submission: Name - Vieworks Co., Ltd. Address - #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu, Seongnamcity, Gyeonggi-do, 462-725 South Korea Telephone – +82-70-7011-6190 Fax - +82-31-737-4954 Contact - Raza, Kim / Sales & Marketing Manager E-mail - lukekim@vieworks.com - 2. Device : | Trade/proprietary name | : QXR-9 | |------------------------|------------------------------------| | Common Name | : Digital Radiography System | | Classification Name | : Solid State X-ray Imaging Device | ### 3. Predicate Devices : に「これ・・・コイ・ア・セット・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | Manufacturer | : IMAGING DYNAMICS COMPANY LTD. | |---------------|-----------------------------------------| | Device | : XAMINER | | 510(k) Number | : K061595(Decision Date - 8. 17. 2006) | | Manufacturer | : Swissray International, Inc. | | Device | : AddOn Multi System | | 510(k) Number | : K973710(Decision Date - 12. 18. 1997) | ## 4. Classifications Names & Citations : 21CFR 892.1650, MQB - Solid State X-ray Imaging Device, Class 2 #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-725 South Korea {1}------------------------------------------------ ### 5. Description : - 5.1 General The QXR-9 Digital Radiography Systems is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of Detector, Power Supply Unit, Accessories, and S/W, The S/W is operated at a workstation that is using Windows XP based OS as its operating system. The system allows the operator to acquire and display images(Image size : 3072x3072 pixels) on 1600 x1200 high resolution monitor. Various features of S/W such as image inversion, image processing, zooming, panning, window level adjustment, contrast adjustment etc enable the operator to view diagnostic details difficult to see using conventional non-digital techniques. #### 5.2 Features - One Charge Coupled Device (CCD) armed with one lens. - 17" x17" imaging area with 3072 x 3072 image format. - High resolution image with 3.5lp/mm - Wide dynamic range with 14-bit digilization - SAW is designed to be operated on MS Windows XP operating system - Image process parameters are selectable according to the body part to make best images for diagnosis - Make copy of images to a CD or DVD or an external USB storage - No x-ray generator control - DICOM3.0 standard compliance - DICOM printer and laser printer compatible - Image Acquisition within 3.5 seconds after x-ray exposure - Display processed image within 10 seconds after x-ray exposure - Non-Processed image can be displayed by using Preview function - 6. Indication for use : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . QXR-9 Digital Radiography system is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-725 South Korea {2}------------------------------------------------ KC73056 Page 3 of 3 screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography. - 7. Comparison with predicate device : Vieworks Co., Ltd. believes that the Digital Radiography System (QXR-9) is substantially equivalent to to Xaminer of IMAGING DYNAMICS COMPANY LTD. and AddOn Multi System of Swissray International, Inc.. - 8. Safety, EMC, Biocompatibility and Performance Data : Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 and IEC 60601-1-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Biocompatibility testing was conducted in accordance with Standard ISO 10993-1. Non-clinical & Clinical considerations according to FDA Guidance for the Submission of 510(k) @for Solid State X-ray Imaging Devices? was performed. All test results were satisfactory. - 9. Conclusions : In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Vieworks Co., Ltd. concludes that the Digital Radiography System(QXR-9) is safe and effective and substantially equivalent to predicate devices as described herein. - 10. Vieworks Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA. END #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-725 South Korea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Viewworks Co., Ltd % Mr. Morten Simon Christensen Staff Engineer/Office Coordinator Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230 AUG 2 3 2013 Re: K073056 Trade/Device Name: Digital Radiography System/QXR-9 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 15, 2007 Received: October 30, 2007 Dear Mr. Christensen: This letter corrects our substantially equivalent letter of November 13, 2007. 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 for use stated in the enorosale) to 10gm.) to 10gm.) 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 I va may, and on one 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, accitional of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 nredicate 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 Parts 801 and 11 you don't open and the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the I ou may other other guiter granational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number(if known): Kc73056 Device Name: Digital Radiography System/ QXR-9 Indications for Use: QXR-9 Digital Radiography system is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE) Page 1 of _1 Tonni M. Wht (Division Slan-Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 30000062