RADMAX Digital Imaging Software

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March 8, 2019 DRGEM Corporation % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071 Re: K182537 Trade/Device Name: RADMAX Digital Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 11, 2019 Received: January 29, 2019 Dear Mr. Alletto: 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. 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 located 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. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, Hsl. 2. Nils Thalia Mills, Ph.D. 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) K182537 Device Name RADMAX Digital Imaging Software #### Indications for Use (Describe) The RADMAX Digital Imaging Software, used together with a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data. The X-ray generator is not part of the RADMAX Digital Imaging Software, device. If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator. However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mAs or kVP, mA or density). Type of Use (Select one or both, as applicable) | <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span style="text-decoration: overline;">☐</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}------------------------------------------------ This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.87(h): ### Date Prepared: January 9, 2019 Submitter's Information: 21 CFR 807.92(a)(1) Mr. Ki-Nam YANG Director | QM representative DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Product Name: RADMAX Digital Imaging Software Common Name: Picture, archive and communications system Classification Name: System, Image Processing, Radiological Product Code: LLZ ## Predicate Device: 21 CFR 807. 92(a)(3) The RADMAX Digital Imaging Software is substantially equivalent to K123650: | Device Classification Name | System, Image Processing, Radiological | |------------------------------|------------------------------------------------------| | 510(K) Number | K123650 | | Device Name | ARIX RAD ACQUISITION CONSOLE | | Applicant | COMPANIA MEXICANA DE RADIOLOGIA CGR,<br>S.A. DE C.V. | | Regulation Number | 892.2050 | | Classification Product Code | LLZ | | Decision Date | 02/20/2013 | | Decision | Substantially Equivalent (SESE) | | Requlation Medical Specialty | Radiology | | Summary | Summary | | Type | Traditional | Device Description: 21 CFR 807 92(a)(4) The RADMAX Digital Imaging Software from DRGEM Corporation, is a digital Xray image processing system designed for acquiring images and processing acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The X-ray generator or digital detector is not part of the RADMAX Digital lmaging Software, device. The RADMAX Digital Imaging Software does not control exposure or electrical charge and X-ray calibration. If the X-ray generator does not allow interfacing with external software like the RADMAX Digital Imaging Software device, then the software cannot be interfaced with X-ray {4}------------------------------------------------ Generator. The RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (KVp. mA second or kVp. mAs) according to the defined value determined by each X-ray company. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data. The RADMAX Digital Imaging Software device is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. The Users must be qualified to create and diagnose radiological image data. The main functions of the RADMAX Imaging Software are as follows: - . Acquisition and storage of digital X-ray images from a digital X-ray Detector. - Input Study information (patient information, exam information). . - . Management of stored (archived) images. - Image processing for enhancement of archived images. ● - Review of stored images. ● - Editing of images. ● - DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) ● - For a DR system (X-ray machine and generator and Digital X-rav detector, etc.) or a need to interface with installed X-ray system, the: - Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions. - -Communication between the Generator Console and the RADMAX device. The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the RADMAX Digital Imaging Software device since the RADMAX device can only interface and control the Generator by the algorithm provided by the X-ray Company. The RADMAX device can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company. The RADMAX Digital Imaging Software, device does not control exposure or electrical charge and or calibration of the X-ray equipment. If the X-ray generator does not allow interfacing with an external software like the RADMAX Imaging Software, then RADMAX, cannot be interfaced with the X-rav Generator. ### Indications for Use: 21 CFR 807 92(a)(5) The RADMAX Digital Imaging Software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data. The X-ray generator is not part of the RADMAX Digital Imaging Software, device. If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator. However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-C, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mA, Time, or kVP, mAs or kVP, mA or density). {5}------------------------------------------------ ## Technological Characteristics: 21 CFR 807 92(a)(6) RADMAX Digital Imaging Software, is a software device that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use. The following table compares the predicate device and the new device. Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices. | Item | Functionality | Subject Device: RADMAX<br>Digital Imaging Software | Predicate K123650<br>ARIX RAD Acquisition<br>Console | If different, Impact on Safety and or<br>Efficacy | |------|--------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Computer &<br>Operating System | Microsoft Windows 10<br>(minimum) | Microsoft Windows<br>XP/Windows 7<br>(minimum) | Yes, there is a difference. Differences are<br>in the processor speeds, Windows<br>operating system, amount of RAM<br>memory, monitors, and hard drive space<br>requirements. These differences are due<br>to the state of computer technology that<br>was available at the time the predicate<br>device was developed. There is "No<br>impact on safety or efficacy" and there are<br>no new potential or increased safety risks. | | 2 | Intended use | Acquiring, viewing, editing<br>and storing radiographs and<br>related patient images | Same | No difference | | 3 | Intended user | radiologist | radiologist | No difference | | 4 | Network | 10/100/100 Ethernet | Same | No difference | | 5 | Monitor | Two color display adaptors<br>1920x1080 | 19-inch monitor using<br>1280x1024 | Yes, there is a difference. See item 1<br>above. | | 6 | User interaction/input | Mouse, keyboard, touch<br>monitor | Same | No difference | | 7 | Multi-user | Available, but at a time, only<br>one user can use it | Same | No difference | | 8 | Import / export<br>images | Yes | Yes | No difference | | 9 | Acquisition devices | Digital X-Ray detectors | Digital X-Ray<br>detectors | No difference | | 10 | Imaging interfaces | Detector dependent | Detector dependent | Yes, there is a difference. Subject device<br>uses Flat panel detectors cleared by FDA:<br>K171138, & K172951 | | 11 | Image organization | Yes. Patient ID, Name,<br>study instance UID | Same | No difference | | 12 | Image search<br>available | Yes | Yes | No difference | | 13 | Image storage | Yes | Yes | No difference | | 14 | Database software | MySQL | MySQL | No difference | | 15 | Image viewing | Yes | Yes | No difference | | 16 | Image measurement | Yes | Yes | No difference | | 17 | Image annotation | Yes | Yes | No difference | | 18 | Image operations | Yes | Yes | No difference | | 19 | Security | Yes (Priority by user) | Same | No difference | | 20 | DICOM 3.0<br>compatibility | Yes | Yes | No difference | | 21 | Generator Control | Yes | Yes | No difference | | 22 | Generator Control<br>Protocol | Generator dependent | Generator dependent | No difference | {6}------------------------------------------------ | Item | Functionality | Subject Device: RADMAX<br>Digital Imaging Software | Predicate K123650<br>ARIX RAD Acquisition<br>Console | If different, Impact on Safety and or<br>Efficacy | |------|-------------------------------------------------------|----------------------------------------------------|------------------------------------------------------|---------------------------------------------------| | 23 | RAW Image data<br>processing | Yes | Yes | No difference | | 24 | Post image data<br>processing | Yes | Yes | No difference | | 25 | RIS code manager | Yes | Yes | No difference | | 26 | Worklist | Yes | Yes | No difference | | 27 | Patient size/Laterality | Yes | Yes | No difference | | 28 | Display radiographic<br>technique, kV, mA,<br>ms, mAs | Yes | Yes | No difference | | 29 | Thumbnail viewing | Yes | Yes | No difference | | 30 | Login | Yes | Yes | No difference | | 31 | New patient manual<br>register | Yes | Yes | No difference | | 32 | X-Ray generator<br>window | Yes | Yes | No differences | | 33 | Bucky selection | Yes | Yes | No difference | | 34 | Body part | Yes | Yes | No difference | | 35 | Generator status<br>display | Yes | Yes | No difference | | 36 | Image reset | Yes | Yes | No difference | | 37 | panning | Yes | Yes | No difference | | 38 | Magnify glass | Yes | Yes | No difference | | 39 | Fit image | Yes | Yes | No difference | | 40 | Image Stitching | Yes | Yes | No difference | | 41 | Series/Image list | Yes | Yes | No difference | #### Nonclinical Testing: The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the RADMAX Digital Imaging Software and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. ### Conclusion: 21 CFR 807 92(b)(1) The 510(k) Pre-Market Notification for the RADMAX Digital Imaging Software, device contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device. Therefore, RADMAX Digital Imaging Software, is substantially equivalent to the predicate device.