PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM

{0}------------------------------------------------ K130088 Page 1 of 4 #### 510(k) Summary Exhibit 5 Date of Summary Preparation: Dec 21, 2012 # JUL 1 8 2013 | 1. | Submitter and US Official Correspondent | | |----|-----------------------------------------|-----------------------------| | | Submitter: | GENORAY Co., Ltd. | | | Address: | #512, Byucksan Technopia | | | | 434-6. Sangdaewon 1-dong. | | | | Jungwon-gu, Seongnam-city | | | | Gyeonggi-do, 462-716, Korea | | | Telephone No.: | +82-31-740-4100 | | | Fax: | +82-31-737-8018 | Official Correspondent (U.S): Jae Kim - Business Manager | Correspondent : | GENORAY America Inc. | |-----------------|----------------------------------------------| | Address: | 1073 N, Batavia St.<br>Orange, CA 92867, USA | | Telephone No.: | 855-436-6729 | | Fax: | 714-786-8919 | | Email: | jac@genorayamerica.com | - 2. Establishment Registration Number 3005843418 #### ਤੇ . Device Information Proprietary/Trade Name: Digital x-ray sensor system / PortView Common/Usual Name: Digital x-ray sensor system / Intraoral X-ray sensor system Classification Name: Digital x-ray sensor(Intraoral sensor) system to capture Extraoral X-ray source Product Codc: MUH Device Class: Class II per regulation 21 CFR 872.1800 - 4. Equivalent Legally Marketed Device | Company | Device Name | K-Number | |---------------------------|-----------------------------------------------|----------| | Schick Technologies. Inc. | Schick Computed Oral Radiology System.<br>CDR | K072134 | | Edlen Imaging LLC | Gemini DUSB | K103290 | {1}------------------------------------------------ #### 5. Description of the Device The digital x-ray sensor system, Port View produces instant, digital, intra-oral x-ray images of a patient's mouth for diagnosis of the tecth and oral structures. It consists of digital intraoral sensors and image processing software as followings. Digital Intraoral sensor: is an indirect light converting digital X-ray detector. Incident X-rays are converted to visible light by a scintillating device. (material) such as Csl(Cesium lodide), the light is coupled optically to a light detection imager which is based on CMOS technology. The sensor supports USB 2.0 Direct connectivity to personal computers and or laptops. Image processing software; provides various functions such as Image acquisition. Image scarch, Image Processing including Enhancement. 21) analysis (Zoom. Rotate, and Measurement) and Image Printing & Saving and DICOM 3.0 application. It can operate on any hardware platform which mects the minimum requirements that Intel Pentium Dual-Core 2.5GHz with Windows XP operating system. | Items | Product | PortView | |-------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Manufacturer | GENORAY Co., Ltd. | | | Product Name | PortView | | | 510(k) No. | | | | Implementation | Software and Sensor | | | Indications for use | PortView is indicated for use in acquiring<br>images of patient teethes. It is intended for<br>intra oral x-ray examinations and<br>produces instant, digital, intra-oral x-ray<br>images of a patient's mouth for diagnosis<br>of diseases of the teeth and oral structures. | | | Size<br>(mm) | Size1: 36.73 X 24.35<br>Size2: 42.8 X 30.49 | | Intra oral sensor | Active Arca<br>(mm²) | Size1: 600<br>Size2: 900 | | | Technology | CMOS | | | Interface to PC | USB 2.0 | | | Dynamic Range | 4096:1 | | | Cable length(m) | 3 | | | Specification | 1. Software name : PortView<br>2. Software version : 1.0<br>3. File size : 100MB<br>4. Language : C++<br>5. DICOM 3.0 Support | | | CPU | Intel Pentium Dual-Core 2.5GHz(E5200) or<br>higher | | | Memory | 1GB or higher | | Software | HDD | 10GB or higher (Client)<br>100GB or higher | | | VGA | Onboard chipset or higher | | | OS | Windows XP or higher | | | DICOM<br>Compliance | DICOM 3.0 | | | IMAGE ARCHIVE | DCM, BMP, JPG, PNG | | | WINDOWING | Adjust the Window width and level for<br>contrast windowing parameters. | {2}------------------------------------------------ #### Indications for use/ Rationale for Substantial Equivalence Q. The PortView is to be used as a digital intra oral sensor system of X-rays in Dental radiography. The PortView shares the same indication for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed above No.4. There are many independent manufacturers of intraoral s-ray dental radiography svstems in the United States today. One is Schick Computed Oral Radiology System. CDR by Schick Technologies. Inc. (K0752134). The other currently marketed device is the Gemini DUSB by Edlen Imaging LLC. (K103290) A comparison table for the different systems is available in the section on Substantial Equivalence and No.7 below. The device has been tested by a third party and found to meet the international safety standards established by the IEC 60601-1, further details available in the section on Test report. | Manufacturer | GENORAY Co., Ltd. | Schick Technologies. Inc. | Edlen Imaging LLC | |-----------------------------|----------------------------------------------------|----------------------------------------------------------------|---------------------------------------------| | Product Name | PortView | Schick Computed Oral<br>Radiology System.<br>CDR | Gemini DUSB | | Implementation | Software and Sensor | Software and Sensor | Sensor Only | | Sensor size<br>(mm) | Size1: 36.73 X 24.35<br>Size2: 42.8 X 30.49 | Size 1: 31 X 22<br>Size 2: 37 X 24<br>Size 2: 43 X 30 | Size1: 36.73 X 24.35<br>Size2: 42.8 X 30.49 | | Sensor Active Area<br>(mm²) | Size1: 600<br>Size2: 900 | Size1: 432<br>Size2: 600<br>Size3: 921 | Size 1: 600<br>Size2: 900 | | Technology | CMOS | CMOS | CMOS | | Interface to PC | USB 2.0 | USB 2.0 | USB 2.0 | | Dynamic Range | 4096:1 | 4096:1 | 4096:1 | | Cable length(m) | 3 | 2 | 3 | | CPU | Intel Pentium Dual-Core<br>2.5GHz(E5200) or higher | Intel Pentium IV or AMD<br>3GHz<br>or higher | 2.0 GHz Pentium 4 | | Memory | 1GB or higher | 1 GB | 1GB | | HDD | 10GB or higher (Client)<br>100GB or higher | 80 GB HD | 80GB | | OS | Windows XP service pack<br>2 or higher | Windows XP Professional<br>or<br>Windows Vista Home<br>Premium | Windows XP Pro / 7 | | DICOM Compliance | DICOM 3.0 | DICOM 4.5 | DICOM 3.0 | | Monitor Settings(Min.) | 1024 X 768 | 1024 X 768 | 1024 X 768 | #### 7. Substantial equivalence chart (Technological Characteristics) {3}------------------------------------------------ K130088 Page 4 of 4 #### 8. Safety, EMC and Performance data The basic safety and essential performance testing according to standard IEC 60601-1 were performed. EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory. And the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices. #### 9. Conclusion The PortView is determined to be substantially equivalent to other legally marketed devices in the United States. They are the Schick Computed Oral Radiology System, CDR by Schick Technologies. Inc. and the Gemini DUSB by Edlen Imaging LLC. We believe that the PortView is safe, effective and substantially equivalent to the predicate devices. {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal 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. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 18, 2013 GENORAY Co., Ltd. % Mr. Jae Kim Business Development Manager GENORAY America, Inc. 1073 N. Batavia Street ORANGE CA 92867 Re: K130088 Trade/Device Name: PortView, digital x-ray sensor system Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: April 23, 2013 Received: April 26, 2013 Dear Mr. Kim: 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. {5}------------------------------------------------ Page 2 - Mr. Jae Kim If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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.lda.gov/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance 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, for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K130088 Device Name: Digital x-ray sensor system, PortView Indications for Use: PortView is indicated for use in acquiring images of patient teeth. It is intended for intra oral x-ray examinations and produces instant, digital, intra-oral x-ray images of a patient's teeth for diagnosis of diseases of the teeth and oral structures. The digital x-ray sensor system, PortView consists of Image acquisition part as an Intraoral Sensor and Image processing Software which provides functions such as Image acquisition, store, and search and connects to Network. And the software can also display images from intra oral video cameras. V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Smh.7) (Division Sign-Off) Division of Radiological I Icalth Office of In Vitro Diagnostics and Radiological Health > 510(k) _______________________________________________________________________________________________________________________________________________________________________ K130088_______________________________________________________________________________________________________________________________________________________________________ Page 1 of 1