INNOVISION-EXII

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 3, 2025 DK Medical System % Dave Kim Medical Device Regulatory Affairs Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON, TX 77054 Re: K242119 Trade/Device Name: Innovision-EXII Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: July 19, 2024 Received: July 19, 2024 Dear Dave 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K242119 Device Name INNOVISION-EXII Indications for Use (Describe) INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # 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." {4}------------------------------------------------ # 510(k) Summary K242119 This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92. # Date 510k summary prepared: - Submitter l. | Submitter's Information: | DK Medical Systems<br>52, Chupalsandan 1-Gil, Paengseong-Eup,<br>Pyeongtaek-Si, Gyeonggi KR 17998<br>+82-2-535-7231<br>Sung-moon Hong (smhong@dk.co.kr) | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Dave Kim (davekim@mtechgroupllc.com)<br>Mtech Group LLC<br>7505 Fannin St., Suite 610, Houston, TX 77054<br>+713-467-2607 | ## II. Subject Device | Trade/proprietary Name | INNOVISION-EXII | |------------------------|------------------------------------| | Common or Usual Name | Digital Radiographic X-ray Systems | | Regulation Name | Stationary X-ray System | | Regulation Number | 21 CFR 892.1680 | | Product Code | KPR | | Regulatory Class | Class II | ## III. Predicate Device | 510K Number | K202572 | |-------------------|------------------------------------| | Manufacturer | DR GEM | | Device Name | GXR-Series Diagnostic X-Ray System | | Regulation Name | Stationary X-ray System | | Regulation Number | 21 CFR 892.1680 | | Product Code | KPR | | Regulatory Class | Class II | # IV. Compatibility: | INNOVISION-EXII | | |-----------------|--| |-----------------|--| | Detector | Clearance(s) | |----------------|-------------------------------------------------------------------------------------------------------------------------------| | Vieworks VIVIX | FXRD-1717VA/VB (K181003), FXRD-2530VAW/VAW PLUS (K200418)<br>FXRD-3643VAW/VAW PLUS (K200418), FXRD-4343VAW/VAW PLUS (K200418) | {5}------------------------------------------------ In the case of Innovation-EXII, it is compatible with the Detector listed in the table above. ## V. Device Description INNOVISION-EXII can receive X-ray signals from X-ray irradiation and digitize them into X-ray images by converting digital images to DICOM image format using Elui imaging software. INNOVISION-EXII is a general radiography X-ray system and not for mammography nor fluoroscopy. In addition, the system must be operated by a user who is trained and licensed to handle a general radiography X-ray system to meet the regulatory requirements of a Radiologic Technologist. Target areas for examinations include the head, spine, chest, and abdomen for diagnostic screening of orthopedic, respiratory, or vertebral discs. The system can capture a patient's postures, such as sitting, standing, or lying. This system can be used for patients of all ages, but it should be used with care for pregnant women and infants. The INNOVISION-EXII system has no part directly touching the patient's body. ## VI. Indications for Use: 21 CFR 807 92 (a) (5) INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use. | Item | Subject Device | Predicate Device | Impact of<br>Differences | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Device Name | INNOVISION-EXII Digital Radiography<br>Systems | GXR-Series Diagnostic<br>X-Ray System (K202572) | Not applicable | | Manufacturer | DK Medical Systems | DRGEM Corporation | Not applicable | | Model Number | | GXR-S series | Not applicable | | Indications for use | INNOVISION-EXII is a stationery X-ray<br>system intended for obtaining<br>radiographic images of various anatomical<br>parts of the human body, both pediatrics<br>and adults, in a clinical environment.<br>INNOVISION-EXII is not intended for<br>mammography, angiography,<br>interventional, or fluoroscopy use. | GXR-Series Diagnostic X-ray system<br>is a stationary X-ray imaging<br>system, for the purpose of<br>acquiring X-ray images of the<br>desired parts of a patient's<br>anatomy. This device is not<br>intended for mammography or<br>bone density applications. | Equivalent | | Conventional<br>film/screen<br>systems or CR<br>cassettes | Comes with FDA cleared digital x- ray<br>panels. Conventional film and CR<br>cassettes can still be used. | Comes with FDA cleared digital x-<br>ray panels. Conventional film and<br>CR<br>cassettes can still be used. | Equivalent<br>Functionality | | Operator console | GUI-based | Same | Similar Functionality | | Power Source | AC LINE | AC LINE | Same | ### VII. Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table {6}------------------------------------------------ | High Voltage generator | | | | | | | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--|--|--| | Output Power | 50kW, 80kW | 32KW, 40KW,<br>52KW, 68KW,<br>82KW | The X-ray<br>generator's output<br>power is different. | | | | | Generator<br>models | CPI CMP 200 (32kW to 100kW) | GXR-32, GXR-40, GXR- 52, GXR-<br>68, GXR- 82 (manufactured by<br>DRGEM) | Yes, there is a<br>difference.<br>Models have<br>been tested<br>against<br>International<br>Safety and EMC<br>Standards. | | | | | Line voltage | 3 phase 400VAC ± 10% | 220~230VAC,<br>380/400/480VA C, | Yes, there are<br>differences in line<br>voltage depending<br>upon the system<br>requirements. | | | | | Components / Parts | | | | | | | | Patient table | | | | | | | | Configuration<br>model | TE-200 | PBT-4, PBT-6, PDT-1 | | | | | | Movement | *Up/down moving distance of table:<br>350mm ±10mm<br>*Moving distance of left/right: 600mm<br>+10mm<br>*Moving distance of forward/backward:<br>250mm±10mm | Longitudinal : 1000mm ± 500mm | The movement<br>range is<br>different. | | | | | Detector Stand | | | | | | | | Configuration<br>model<br>Dimension/weight | DS-200<br>780(W) x 849(D) x 2224(H) mm /<br>125kg (256lbs) | WBS, WBS-TM<br>659(W) x 445(D) x<br>1,599(H)mm / 110kg(242lbs)<br>659(W) x 445(D) x<br>1,749(H)mm / 113kg(249lbs)<br>659(W) x 445(D) x<br>1,919(H)mm / 116kg(255lbs)<br>659(W) x 445(D) x | The weight is<br>different. | | | | {7}------------------------------------------------ | Ceiling suspended X-ray tube support | | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Configuration<br>model | Elin-T7 | TS-FC6, TS-FC4, TS- FC2<br>TS-FM6, TS-CSA, TS- CSE | The tube stand model and<br>rotation range are different. | | Tube<br>Rotation<br>Angle | ±180° | ±135° | | | X-ray tube | | | | | Configuration<br>model | canon E7869X<br>Varex RAD-14 Diamond | E7239X, DXT-8M, E7242X,<br>DXT-11M E7843X, DXT-10M<br>E7876X, DXT-12M E7884X,<br>E7252X DXT-14U, RAD-14U,<br>DXT-15U, RAD-21 RAD-60,<br>E7255FX, E4254FX | The X-ray tube configuration is<br>different. | | Max. kV | 150kV | 125kV, 150kV | | | Collimator | | | | | Configuration<br>model | Ralco R225ACS | DXC-RML, DXC-RMH MCR,<br>R108, R302A, R302MLP/A,<br>R302MFMLP/A | The collimator model and<br>configuration are different. | | Detector | | | | | Configuration<br>model | FXRD-1717 VA/VB – K181003<br>FXRD-2530VAW/VAW PLUS –<br>K200418<br>FXRD-3643VAW/VAW PLUS –<br>K200418<br>FXRD-4343VAW/VAW PLUS –<br>K200418<br>FXRD-2530FAW - K221512<br>FXRD-3643FAW - K221512<br>FXRD-4343FAW - K221512<br>FXRD-1717SA/SB – K122866<br>FXRD-1417SA/SB – K122866<br>FXRD-1417WA/WB - K122865<br>FXRD-1717NA/NB - K152894<br>FXRD-1417NAW/NBW -<br>K163703<br>FXRD-1012NAW/NBW -<br>K152885 | VAREX, 4343R v3 -<br>K172951<br>VAREX, 4336W v4-<br>K161459<br>VAREX, XRpad2 3025<br>HWC-M- K161942<br>VAREX, XRpad2 4336<br>HWC-M- K161966<br>VAREX, XRpad2 4343<br>HWC-M- K181526<br>i-Ray,<br>Mano4336WK201004<br>i-Ray,<br>Mano4343WK201043<br>Vieworks, VIVIX-S1417N<br>(NAW, NBW)-K163703<br>Vieworks, VIVIX-S1717N<br>(NAW, NBW)- K152894<br>VAREX, 4343W- K161459 | There are differences for detector.<br>However, All the flat panel detectors<br>have been previously cleared by<br>510(k).<br>And the system has been tested<br>and a risk analysis has been<br>performed, and it has been<br>concluded that there is no<br>adverse effect on safety or<br>effectiveness | | Safety /<br>Performance<br>Test<br>Standards | 60601-1: 3.2 ed; 60601-1-2: 4.1<br>ed. 60601-4-2 (Essential<br>performance),<br>60601-2-54 Edition 1.2,<br>NEMA PS 3.1 - 3.20(2011)<br>21CFR 1020.30, 21CFR 1020.31 | Same | Same | # VIII. Non-clinical testing Testing was performed successfully according to the following standards: -Electrical safety and EMC INNOVISION-EXII has been tested for electrical safety standard IEC 60601-1: 3.2 Ed and electromagnetic compatibility IEC 60601-1-2: 4.1 Ed. {8}------------------------------------------------ The software validation and verification testing were also performed. The results of nonclinical testing indicate that the INNOVISION-EXII is as safe and effective as the predicate device. Compliance evidences were submitted for the following standards: | Std # | Safety/EMC Standards Description | FDA Rec.<br>Standard # | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | IEC 60601-1-3 | Edition 2.2 2021-01, Medical electrical equipment<br>Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment | 12-269 | | IEC 60601-1-6 | IEC 60601-1-6 Edition 3.2 2020-07<br>Medical electrical equipment - Part 1-6: General requirements for basic safety and essential<br>performance - Collateral standard: Usability | 5-89 | | IEC 60601-2-28 | IEC 60601-2-28j Edition 3.0 2017-06<br>Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source<br>assemblies and X-ray tube assemblies for medical diagnosis | 12-309 | | IEC 60601-2-54 | IEC 60601-2-54, Edition 2.0 2022-09<br>Medical electrical equipment<br>Part 2: Particular requirements for the basic safety and essential performance<br>of X-ray equipment for radiography and radioscopy | 12-317 | | IEC 60601-1-2 (EMC) | IEC 60601-1-2 Edition 4.1 2020-09. Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances Requirements and tests. | 19-8 | | IEC 62304:2006 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION<br>Medical device software - Software life cycle processes | 13-79 | | IEC 60601-1 | Edition 3.2, 2020, Medical electrical equipment, Part 1: General requirements for basic<br>safety and essential performance | 19-4 | | ISO 14971:2019 | ISO 14971:2019 Third Edition, Medical devices - Applications of risk management to medical<br>devices. | 5-125 | | ISO 15223-1 | ISO 15223-1 Fourth Edition 2021-07, Medical devices - Symbols to be used with<br>medical device labels, labelling, and information to be supplied - Part 1: General<br>requirements. | 5-134 | | TR 60601-4-2 | TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and<br>interpretation - Electromagnetic immunity: performance of medical electrical equipment<br>and medical electrical systems | 19-19 | | NEMA PS3.1-3.20 | DICOM Conformity | 12-342 | | FDA 21CFR 1020 | Electronic product: Performance Standard for Diagnostic X-ray System and Major Components | | | FDA Guidance | Pediatric Information for X-ray Imaging Device Premarket Notifications dated November 28, 2017 | | | FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions:<br>September 27, 2023 | | | FDA Guidance | Content of Premarket Submissions for Device Software Functions: JUNE 14, 2023 | | Digital Imaging Software, Elui-W is a medical imaging software for acquiring patient's X-ray image, processing the readable images in working with diagnostic medical information system and PACS. Elui program consists of Worklist mode that displays information of DICOM and of a patient whose images are to be acquired; Exam mode that displays images, irradiated body parts and filming conditions as well as conducts image processing; Database mode that stores and manages the acquired images and sends them to the server. {9}------------------------------------------------ - Windows based graphic user interface - X-ray generator control panel - Unlimited procedure step - Quick step-add feature and image maintenance feature by popup menu - ROI changing and creation feature - Marker feature (support the creation of unlimited number of markers by user) - Multi-language support - · DAP meter (optional) - · Support DICOM and PACS - High-performance post-processing feature - Copy & Move Images - Dose monitoring function - · Grid line suppression function A detailed risk analysis was performed on the entire system, evaluating successful integration of the various components. ## IX. Clinical testing Clinical image evaluation of INNOVISION-EXII has been performed. The evaluation results demonstrated that INNOVISION-EXII generated images are adequate and suitable for expressing contour and outlines. The image quality including contrast and density are appropriate and acceptable for diagnostic exams. Substantial Equivalence Discussion. INNOVISION-EXII performs the same functions using the same technological methods to produce diagnostic x-ray images. In all material aspects, INNOVISION-EXII and the (GXR-Series Diagnostic X-Ray System ) are substantially equivalent to each other. ### X. Conclusion: INNOVISION-EXII is substantially equivalent to the predicate device the (GXR-Series Diagnostic X-Ray System ) Stationary Radiographic System. Both subject and predicate devices are same or very similar in the intended use, the design principle, the performance and the applicable standards. Therefore, DK Medical concludes INNOVISION-EXII is substantially equivalent with the (GXR-Series Diagnostic X-Ray System) Stationary Radiographic System .