PROMO

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 22, 2025 DRGEM Corporation % Doonam Choi Regulatory Affairs | Engineer 7F, E-B/D Gwangmyeong Techno-Park 60, Haan-ro Gwangmyeong-si, Gyeonggi 14322 SOUTH KOREA Re: K251443 Trade/Device Name: Promo Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: April 29, 2025 Received: July 22, 2025 Dear Doonam Choi: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251443 - Doonam Choi Page 2 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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. {2} K251443 - Doonam Choi Page 3 See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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, 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251443 | | | Device Name PROMO | | | Indications for Use (Describe) | | | The PROMO is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis. | | | 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} DRGEM Your Best Healthcare # 510(k) Summary K251443 This 510(k) Summary of safety and effectiveness information is prepared in accordance with the requirements of 21 CFR 807.92. # 1. SUBMITTER Manufacturer: DRGEM Corporation Address: 7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-Ro Gwangmyeong-Si Gyeonggi, Republic of Korea, 14322 Contact Person: Mr. Doonam Choi Contact Title: Regulatory Affairs / Senior Research Engineer Email: dnchoi@drgem.co.kr Phone Number: +82-70-8230-8617 Fax Number: +82-2-869-8567 Date Prepared: December 27, 2024 # 2. PROPOSED DEVICE INFORMATION Device Name: PROMO Classification Name: Mobile X-ray System Product Code: IZL Regulation Number: 892.1720 Associated Product Code: MQB Regulatory Class: II # 3. PREDICATE DEVICE INFORMATION Device Name: TOPAZ Classification Name: Mobile X-ray System 510(k) Number: K242015 Product Code: IZL Regulation Number: 892.1720 Associated Product Code: MQB Regulatory Class: II page 1 / 6 {5} DRGEM Your Best Healthcare ## 4. DEVICE DESCRIPTION The PROMO is based on predicate device TOPAZ and the x-ray detectors are the same as the predicate system. ### Device Features: The PROMO is moved smoothly with manual by user. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator with excellent performance, lifetime and stability. Digital flat panel detector with CsI screen provides excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator which have worldwide reputation on excellent performance, lifetime and stability. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. ### Device Characteristics: #### Software The PROMO include imaging software that is the RADMAX. The RADMAX software can perform processing the radiological image acquired from solid state x-ray imaging device. The RADMAX software is based on predicate device TOPAZ. The CTR function is a manual quantitative imaging feature that allows users to measure the cardiothoracic ratio by manually selecting points using a mouse. The software function has been verified and validated as safe and effective. #### Software Level Determination The RADMAX software is Basic Documentation Level. This device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets all images and information being displayed and printed. #### Cybersecurity This device complies with cybersecurity requirements by ensuring the confidentiality, integrity, and availability of data and systems. Potential vulnerabilities were identified through cybersecurity risk analysis, which included threat modeling, risk assessment, and the development of a software bill of materials. The design integrates security controls, such as authentication, authorization, encryption, integrity verification, event detection and logging, retention, recovery and secure software updates. Verification and tests were conducted to ensure the effectiveness of the implemented cybersecurity controls. The product labeling includes cybersecurity-related information, and users are provided with guidance and training on instruction for use. ## 5. INDICATION FOR USE The PROMO is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis. page 2 / 6 {6} DRGEM Your Best Healthcare # 6. TECHNOLOGICAL CHARACTERISTICS The PROMO is based on the predicate device TOPAZ (K242015) including the system control, Intended for use and mechanical design. The differences between the subject device and the predicate device have been thoroughly tested and verified for safety and effectiveness by an accredited Safety and EMC testing laboratory. This 510(k) submission describes some modifications to the previously cleared predicate devices the TOPAZ (K242015). For more detail, refer to the "Substantial Equivalence Comparison Table" ## Substantial Equivalence Comparison Table | Item | Subject Device | Predicate Device | Impact of Differences | | --- | --- | --- | --- | | Regulation Description | System, X-ray, Mobile | System, X-ray, Mobile | Same | | Product Code | IZL | IZL | Same | | Regulation Number | 892.1720 | 892.1720 | Same | | Associated Product Code | MQB | MQB | Same | | Regulatory Class | II | II | Same | | Appearance | | | It has been verified according to international safety and EMC standards, and the differences do not negatively impact safety or effectiveness. | | Drive Type | Manual Driven | Electrical motor driven | It has been verified according to international safety and EMC standards, and the differences do not negatively impact safety or effectiveness. | | Output Power Rating (kW) | 40 kW | 40 kW | Same | | mA Range | 10 ~ 500 mA | 10 ~ 500 mA | | | kV Range | 40 ~ 125 kV | 40 ~ 125 kV | | | mAs Range | 0.1 ~ 500 mAs | 0.1 ~ 500 mAs | | page 3 / 6 {7} DRGEM Your Best Healthcare | X-ray tube model | LUC-12L | E7239X | It has been verified according to international safety and EMC standards, and the differences do not negatively impact safety or effectiveness. | | --- | --- | --- | --- | | | | E7242X | | | | | E7299X | | | | | E7876X | | | | | E7884X | | | | | DXT-8M | | | | | DXT-11M | | | | | DXT-10M | | | DXT-12M | | | | | Focal spot | 0.6 mm / 1.5 mm | 1.0 mm / 2.0 mm, 0.3 mm / 1.0 mm, 0.6 mm / 1.2 mm, 0.6 mm / 1.5 mm | | | Target angle | 14 ° | 12° ~ 16° depending upon the Tube | | | Column rotation range | 0 ° (Fixed) | ± 325 ° | The rotation range is narrower compared to the predicate, but there is no negative impact on safety or effectiveness. | | | Option : ±90 ° | ± 330 ° | | | Tube (Arm axis) | ± 180 ° | ± 180 ° | Same | | Tube axis rotation range | -49° ~ +147 ° | -30 °~+90 ° | The rotation range has been extended, but there is no negative impact on safety or effectiveness. | | Collimator | DXC-RML | DXC-RML | Same | | Lamp Type | LED lamp | LED lamp | Same | | DAP meter | 120-131HS (RS485) | 120-131HS (RS485) | Same | | Detector | Mano4336W | Mano4336W | Same | | | Mano4343W | Mano4343W | | | | Mars1417X | Mars1417X | | | | Mars1717X | Mars1717X | | | Imaging software | RADMAX | RADMAX | Same | | Display | 21.5 inch touch screen | 21.5 inch touch screen | Same | page 4 / 6 {8} DRGEM Your Best Healthcare # 7. SUMMARY OF NON-CLINICAL Data This 510(K) premarket notification includes non-clinical performance testing. Tests were performed on the proposed PROMO according to the following FDA recognized standards and guidance document. The verification and validation methods (test methods and acceptance criteria) used to evaluate the proposed PROMO is the same as those used for the predicate device TOPAZ (K242015) and follow International and FDA recognized consensus standards and guidance documents applicable to this device type. | Standards/ Guidance | Title | | --- | --- | | IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | | IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 60601-2-28 Edition 3.0 2017-06 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | | IEC 60601-2-54 Edition 2.0 2022-09 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | | ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk management to medical devices | | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes | | IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION | Medical devices - Part 1: Application of usability engineering to medical devices | | NEMA PS 3.1 - 3.20 2024e | Digital Imaging and Communications in Medicine (DICOM) Set | | IEC 61910-1 Edition 1.0 2014-09 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy | | IEC TS 60601-4-2 Edition 1.0 2024-03 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | | FDA Guidance | Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff, Document issued on November 28, 2017 | page 5 / 6 {9} DRGEM Your Best Healthcare | FDA Guidance | Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff, Document issued on September 1, 2016 | | --- | --- | | FDA Guidance | The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff, Document issued on July 28, 2014 | | FDA Guidance | Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff, Document issued on June 14, 2023 | | FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions- Guidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023 | The subject mobile system PROMO is strongly based on the predicate TOPAZ. The x-ray exposure characteristics are the same and the flat-panel detectors are unchanged from the predicate. Bench testing was conducted to evaluate the image performance of the detector. The results showed that PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution. Therefore, the substantial equivalence in image quality performance is supported by objective bench testing data. # 8. SUBSTANTIAL EQUIVALENCE CONCLUSION The PROMO is substantially equivalent to the currently marketed and predicate device TOPAZ (K242015) in terms of the design features, technological characteristics, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance tests and testing as per FDA-recognized consensus standards. The test results demonstrate that the device conforms to its specifications and is safe and effective for its intended use. page 6 / 6