Exam Vue DR

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2015 JPI Healthcare Co., Ltd. % Mr. William Little Senior Product Manager JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803 Re: K142930 Trade/Device Name: ExamVue DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 2, 2015 Received: April 3, 2015 Dear Mr. Little: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert A Ochs Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142930 Device Name ExamVue DR Indications for Use (Describe) Exam Vue DR is a software for the acquisition, processing, storage and viewing of two-dimensional digital radiology images. Exam Vue DR is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. ExamVue DR is not indicated for use in mammography. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510 (k) Summary #### May 20, 2014 - 1. Company and Correspondant Making the Submission: Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: Wonsik (Stanly) Youn Website: http://www.jpi.co.kr/ - 2. Identification of Device | Classification Name: | System, Image Processing, Radiological | |-------------------------|----------------------------------------| | Common Name: | Digital X-ray Acquisition Software | | Trade/Proprietary Name: | ExamVue DR | - 3. Predicate Device | Manufacturer: | IMFOU Co, Ltd | |----------------|---------------| | Device: | feel-DRCS | | 510(k) Number: | K110033 | - Product Classification Names and Citations 4. Regulatory Number: 21 CFR 892.1680 Regulatory Class: II Product Code: 90 KPR - 5. Description: The Exam Vue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3tt party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol. {4}------------------------------------------------ ### 6. Indication for use ExamVue DR is a software for the acquisition, processing, storage and viewing of digital x-ray images. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. ExamVue DR is not indicated for use in mammography. ### 7. Comparison with Predicate Device: JPI Healthcare Co., Ltd, believes that the ExamVue DR software is substantially equivalent to the feel-DRCS software of IMFOU. The ExamVue DR software and the predicate device both -Provide a user interface for the registration, acquisition, and evaluation of x-ray studies. -Perform the functions of image transfer, image acquisition, image processing, and maintaining a patient database. -Use the DICOM 3.0 standard for medical imaging -Are intended for installation on Windows operating systems for use in a medical environment. -Interface with and process images from multiple models of hardware. ExamVueDR and the predicate device share the same essential functions of image acquisition, transfer, and processing; however they have different user interfaces and different computer hardware and operating system requirements. We believe this does not represent a substantial difference between the two devices, as the change in system requirements reflect the change in computer technology since the release of the predicate device, and the user interface presents the same essential data and supports similar workflow as the predicate device. 7. Safety, EMC and Performance Data Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. We have also provided performance and clinical testing using example X-ray detectors, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" ## 8. 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 JPI Healthcare Co., Ltd. concludes that ExamVue DR is safe and effective {5}------------------------------------------------ and substantially equivalent to predicate devices as described herein.