ASHK100G

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 30, 2019 LG Electronics % Jinhwan Jun Chief Research Engineer 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si. 17709 Gyeonggi-do REPUBLIC OF KOREA Re: K191188 Trade/Device Name: ASHK100G Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 30, 2019 Received: May 3, 2019 Dear Jinhwan Jun: 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 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); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191188 Device Name ASHK100G Indications for Use (Describe) Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.) | Type of Use (Select one or both, as applicable) | <table><tr><td><span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span></td></tr></table> | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo consists of two parts: a stylized face inside a circle on the left and the letters 'LG' on the right. Below the letters 'LG' is the slogan 'Life's Good' in a smaller font. The face inside the circle is red, and the letters 'LG' and the slogan are in a dark gray color. # 510(k) Summary K191188 [As Required by 21 CFR 807.92] #### 1. Date Prepared [21 CFR 807.92(a)(a)] April 30, 2019 #### 2. Submitter's Information [21 CFR 807.92(a)(1)] | • | Name of Sponsor: | LG Electronics | |---|-----------------------|--------------------------------------------------------| | | Address: | 222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, | | | | Gyeonggi-do, Republic of Korea | | • | Contact Name: | Jinhwan Jun / Chief Research Engineer | | | Telephone No.: | +82-31-8066-5641 | | | Email Address: | jinhwan.jun@lge.com | | • | Name of Manufacturer: | LG Electronics | | | Address: | 77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, Republic o | | | | Korea, 3938 | #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name (Model Name) | ASHK100G | |-----------------------------|---------------------------------------------| | Product Name | LG Acquisition Workstation Software | | Device Classification Name | Picture archiving and communications system | | Regulation Number | 21 CFR 892.2050 | | Classification Product Code | LLZ | | Product Code Name | System, Image Processing, Radiological | | Device Class | II | | 510k Review Panel | Radiology | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle and the letters "LG" in a sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller, italicized font. # 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate Device | • 510(k) Number: | K160579 | |--------------------------------|----------------------------------------------------------------| | • Applicant: | Rayence Co., Ltd. | | • Trade Name: | XmaruView V1, Xmaru Chiroview, Xmaru Podview and Xmaru<br>PACS | | • Common Name: | Radiological Image Processing System | | • Classification Name: | Picture archiving and communications system | | • Regulation Number: | 21 CFR 892.2050 | | • Classification Product Code: | LLZ | | • Device Class: | II | - 510(k) Review Panel: Radiology ● ## 5. Description of the Device [21 CFR 807.92(a)(4)] ASHK100G is digital radiography operating console software. ASHK100G provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, ASHK100G acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer. # 6. Indications for Use [21 CFR 807.92(a)(5)] Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the LG logo. The logo consists of a red circle with the letters 'L' and 'G' inside, and the letters 'LG' in gray next to the circle. Below the letters 'LG' is the slogan 'Life's Good' in a smaller font. ### 7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)] ASHK100G is medical software. It digitalizes the signal sent from the detector and displays the x-ray image. Also, it can enter patient information, shot information, and other necessary references for convenience. Compared with the predicate device, the technological characteristics of the proposed device, ASHK100G, are substantially equivalent to those of the predicate device. The proposed device is functionally similar to the predicate device. | | Proposed Device | Predicate Device | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | Not known | K160579 | | Manufacturer | LG Electronics | Rayence Co., Ltd. | | Trade Name | ASHK100G | XmaruView V1, Xmaru Chiroview,<br>Xmaru Podview and Xmaru PACS | | Common Name | Radiological Image Processing<br>System | Medical Image Processing<br>Software | | Product Code | LLZ | LLZ | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | | 510(k) Review Panel | Radiology | Radiology | | Indications for Use | Software used in a device that saves,<br>enlarges, reduces, views as well as<br>analyzes, transfers and prints medical<br>images. (excluding fluoroscopic,<br>angiographic, and mammographic<br>applications.) | XmaruView V1(Xmaru Chiroview<br>or Xmaru Podview) software<br>carries out the image processing<br>and administration of medical X-<br>ray data which includes<br>adjustment of window leveling,<br>rotation, zoom, and<br>measurements. XmaruView<br>V1(Xmaru Chiroview or Xmaru<br>Podview) is not approved for<br>mammography and is meant to<br>be used by qualified medical<br>personnel only. XmaruView<br>V1(Xmaru Chiroview or Xmaru<br>Podview) is complying with<br>DICOM standards to assure<br>optimum communications<br>between network systems. Xmaru<br>PACS receives, stores, searches<br>and views the diagnostic image<br>data from imaging modalities in<br>DICOM compliant. Xmaru PACS is<br>capable of communicating with<br>electronic medical records<br>systems, hospital information | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face inside a circle and the letters "LG" in a sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller, italicized font. | | Proposed Device | Predicate Device | |-------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | systems, and radiology<br>information system via DICOM standard. XmaruView V1(Xmaru<br>Chiroview or Xmaru Podview) and Xmaru PACS can be packaged<br>together or offered as a stand-alone imaging solution to be<br>installed in a PC for trained medical professionals. | | Processor | Intel® Core i5 or higher | Intel® Core i3 or higher | | RAM | 8GB or higher | 4GB or higher | | Hard Disk | min. 500GByte | min. 80GByte | | Network | 100MBit or 1GBit | 100MBit or 1GBit | | Operation Software | Microsoft Windows 7(64 bit)<br>Microsoft Windows 8(64 bit)<br>Microsoft Windows 10(64 bit) | Microsoft Windows 7(32 bit / 64 bit)<br>Professional<br>Microsoft Windows 8 Professional<br>or Enterprise | | Resolution | min. 1920 x 1080 | min. 1280 x 768 | | Generator Control<br>protocol | YES | YES | | Image Processing | Yes | Yes | | Windowing | Yes | Yes | | Image formatting | Yes (1x1,2x2,3x3,4x4) | Yes (1x1,1x2,2x1,2x2,3x3) | | Electronic zoom | Yes | Yes | | Image rotation | Yes | Yes | | Image annotation | Yes | Yes | | Image Stitch | Yes | Yes | | DICOM Worklist | Yes | Yes | | DICOM Store | Yes | Yes | | DICOM Print | Yes | Yes | | SW Ver. | ver. 1.0 | XmaruView V1(Xmaru Chiroview<br>or Xmaru Podview) - 2.0<br>Xmaru PACS - 1 | # 8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)] The software information of ASHK100G is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the LG logo. The logo consists of a red circle with the letters 'L' and 'G' inside, and the letters 'LG' in gray next to the circle. Below the letters 'LG' is the slogan 'Life's Good' in a smaller font. #### 9. Clinical Test Summary [21 CFR 807.92(b)(2)] This section is not applicable #### 10.Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] There are no significant differences between ASHK100G and the predicate devices, K160579 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics. ## 11.Conclusion [21 CFR 807.92(b)(3)] There are no significant differences between the ASHK100G and the predicate device(s) that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.