(153 days)
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.
The device is not intended for mammography.
The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
The REMEX Xcam6 is a handheld and portable general-purpose X-ray system intended for use by qualified and trained clinicians to obtain diagnostic radiographic images of patient's extremities.
The REMEX Xcam6 serves as an X-ray source and is designed to be used in conjunction with a Flat Panel Detector (FPD), which is not included as part of the system. The FPD is connected to a computer equipped with imaging software that enables image acquisition, display, manipulation, storage, and transmission.
The X-ray source is securely enclosed within the housing of the handheld unit, and the device does not come into direct contact with the patient during use.
During imaging procedures, the patient is positioned appropriately—either sitting or lying down—and the X-ray receptor is aligned accordingly. The patient is instructed to remain still while the operator sets the exposure parameters and initiates the radiographic exposure.
The operator has control over the following exposure parameters:
- Tube Voltage (kVp): Adjustable from 40 to 90 kVp, in 1 kV increments.
- Tube Current (mA): Adjustable from 2 to 6 mA, in 1 mA increments.
- Exposure Time: Adjustable from 0.06 to 2.00 seconds, in 0.01-second increments.
The provided document outlines the FDA 510(k) clearance for the REMEX Xcam6, a portable X-ray equipment. While it confirms the device meets safety and performance standards for substantial equivalence to a predicate device, it does not provide explicit acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) or detailed clinical study results typical for an AI/CADe device.
The document primarily focuses on technical characteristics, electrical safety, image quality (bench testing), and software validation. The "Clinical Performance Testing" section is very limited and only states that a board-certified radiologist verified the images were suitable for diagnostic interpretation, without quantifiable results.
Therefore, many of the requested details, especially those pertaining to a comparative effectiveness study involving AI assistance, multi-reader multi-case studies, or detailed AI performance metrics, are not available in the provided text as this is a traditional X-ray device clearance, not an AI/CADe device clearance.
Below is an attempt to address the questions based only on the information available in the provided FDA 510(k) clearance letter. Missing information will be explicitly stated as "Not provided."
Acceptance Criteria and Device Performance Study for REMEX Xcam6
The REMEX Xcam6 is a mobile X-ray system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device, as indicated by the product code "IZL" (Mobile x-ray system) and the lack of AI-specific claims. Therefore, the acceptance criteria and study detailed in the document focus on demonstrating substantial equivalence to a predicate conventional X-ray system through technical specifications, safety, and image quality for diagnostic interpretation by a human clinician, rather than on AI-driven performance metrics like sensitivity, specificity, or reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical tests (electrical safety, EMC, image quality, dosimetry, software V&V) and a limited clinical test. The "acceptance criteria" for these tests are implicitly that the device performs "as intended" and is "as safe and effective as the predicate device," and that "all predefined acceptance criteria established in the test protocol" were met for bench testing. Specific, quantitative acceptance criteria for image quality beyond "suitable for diagnostic interpretation" are not explicitly stated for the clinical review.
| Acceptance Criteria Category/Metric | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Image Quality (Bench Testing) | Met all predefined acceptance criteria established in the test protocol; image quality characteristics are substantially equivalent to the predicate device. |
| Dosimetry (Bench Testing) | Met all predefined acceptance criteria established in the test protocol; radiation dose characteristics are substantially equivalent to the predicate device. |
| Software Verification & Validation | Performed in accordance with IEC 62304:2006/A1:2015 for Class B software; Cybersecurity addressed per FDA guidance. |
| Clinical Image Quality | Acquired images were reviewed and assessed by a board-certified radiologist, who verified that the image quality was suitable for diagnostic interpretation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly provided. The documentation states "A limited clinical test was conducted." It does not specify the number of images or patients included in this test.
- Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: "A board-certified radiologist" (singular) was stated to have reviewed and assessed the images.
- Qualifications of Experts: "Board-certified radiologist." No specific experience level (e.g., years of experience) is mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided. Given only one radiologist was mentioned for clinical review, a formal multi-reader adjudication method (e.g., 2+1, 3+1) is unlikely to have been performed for this specific clinical assessment. The radiologist's assessment served as the verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. The provided information is for a traditional X-ray system, not an AI-assisted device. The clinical performance testing focused on verifying the image suitability for diagnostic interpretation by a single radiologist, not on human reader performance improvement with AI assistance.
- Effect Size of Human Readers Improvement: Not applicable, as no AI assistance is mentioned or evaluated.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Standalone Study: Not applicable. This device is a hardware X-ray system; it does not feature an AI algorithm that would have standalone performance. Its software controls the X-ray system's operation, not image interpretation.
7. The Type of Ground Truth Used
- Ground Truth Type: For the "limited clinical test," the "ground truth" for verifying image quality appears to be the subjective assessment and verification by a single "board-certified radiologist" that the images were "suitable for diagnostic interpretation."
- For bench testing, phantoms were used, with "predefined acceptance criteria" as the ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This product is a physical X-ray machine. It does not utilize an AI model that requires a training set in the conventional sense. The software mentioned (IEC 62304 Class B) relates to the operational control of the device, not image analysis or AI interpretation.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no AI model or training set specified for this device.
FDA 510(k) Clearance Letter - REMEX Xcam6
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 31, 2025
REMEDI Inc.
℅ Seong-Geun Park
Regulatory Manager
#1408, IS BIZ Tower Bldg 1, 26 Yangpyeong-ro 21 Gil 26,
Yeongdeunpo-Gu, Yeongdeunpo-Gu
SEOUL, 072NN
SOUTH KOREA
Re: K250597
Trade/Device Name: REMEX Xcam6
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile x-ray system
Regulatory Class: Class II
Product Code: IZL
Dated: December 20, 2024
Received: July 2, 2025
Dear Seong-Geun Park:
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.
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K250597 - Seong-Geun Park 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. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K250597 - Seong-Geun Park Page 3
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250597
Device Name: REMEX Xcam6
Indications for Use (Describe):
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.
The device is not intended for mammography.
The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
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
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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."
Page 5
510(k) Summary: K250597
I. SUBMITTER
REMEDI Inc.
2F, 69-14, Sakju-ro 145beon-gil, Chuncheon-si, Gangwon-do
Republic of Korea, KR 24232
Phone: +82-2-2135-5879
Fax: +82-2-2135-5889
Contact: Seong-geun Park, Regulatory Manager (seonggeun.park@remedihc.com)
II. DEVICE
Name: REMEX Xcam6
Common Name: System, X-Ray, Mobile
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile X-Ray System
Product Code: IZL
Regulatory Class: II
III. PREDICATE DEVICE
Manufacturer: MinXray, Inc. (Northbrook, IL, USA)
Name: TR90BH
Common name: System, X-Ray, Mobile
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile X-Ray System
Product Code: IZL
Regulatory Class: II
510(k) Number: K182207
Page 6
IV. DEVICE DESCRIPTION
The REMEX Xcam6 is a handheld and portable general-purpose X-ray system intended for use by qualified and trained clinicians to obtain diagnostic radiographic images of patient's extremities.
The REMEX Xcam6 serves as an X-ray source and is designed to be used in conjunction with a Flat Panel Detector (FPD), which is not included as part of the system. The FPD is connected to a computer equipped with imaging software that enables image acquisition, display, manipulation, storage, and transmission.
The X-ray source is securely enclosed within the housing of the handheld unit, and the device does not come into direct contact with the patient during use.
During imaging procedures, the patient is positioned appropriately—either sitting or lying down—and the X-ray receptor is aligned accordingly. The patient is instructed to remain still while the operator sets the exposure parameters and initiates the radiographic exposure.
The operator has control over the following exposure parameters:
- Tube Voltage (kVp): Adjustable from 40 to 90 kVp, in 1 kV increments.
- Tube Current (mA): Adjustable from 2 to 6 mA, in 1 mA increments.
- Exposure Time: Adjustable from 0.06 to 2.00 seconds, in 0.01-second increments.
V. INDICATIONS FOR USE
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.
The device is not intended for mammography.
The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table compares technological and other characteristics of the subject and predicate devices.
| REMEX-Xcam6 (Subject Device) | TR90BH (K182207) | Comparison | |
|---|---|---|---|
| Classification & Product code | 892.1720; IZL | 892.1720; IZL | Same |
| Intended Use | Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting | The TR90BH is a portable X-ray system with following limitations of use: | Similar |
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| REMEX-Xcam6 (Subject Device) | TR90BH (K182207) | Comparison | |
|---|---|---|---|
| under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.The device is not intended for mammography.The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types. | The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid.- Not to be used on bariatric patients, unless imaging body extremities- Not for mammography use- The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types. | ||
| Size: Body | 165.3 x 176 x 335.6 mm | 219 x 442 x 190 mm | Different |
| Weight | 2.4 kg (including Cone 190g) | 7.7 kgs (With Battery) | Different |
| Energy Source | Lithium-polymer Rechargeable Battery, 22.2Vdc, 1800mAh | Lithium-ion Rechargeable Battery, 57.6 Vdc, 1900mAh | Different |
| User Interface | Up-Down pushbuttons for selection of exposure time, kV, and mA. | Up-Down pushbuttons for selection of exposure time, kV, and mA. | Same |
| Total Filtration | 3.6mm Al | Minimum 3.0mm Al | Similar |
| Exposure times | 0.06 -2.0 sec (0.01 sec. steps) | 0.01 sec – 1.0 sec: 0.01 sec Step High Power Mode 0.01 sec – 0.3 sec: 0.01 sec Step | Different |
| Tube voltage | 40 - 90 kV (1 kV steps) | 40 – 90 kVp (2 kV steps) | Similar |
| Tube Current (mA) | 2 ~ 6 mA @ 40 to 80 kV2 ~ 5 mA @ 81 to 90 kV | 20 mA@40-60 kVDC15 mA@62-80 kVDC10 mA @82-90 kVDC15mA@82-90 kVDC in High Power Mode(2kVp steps) | Different |
| Maximum Output(mAs) | 12 mAs @ 40 to 80 kV10 mAs @ 81 to 90 kV | 20 mAs@40-60 kV15 mAs@62-80 kV3 mAs @82-90 kV4.5 mAs@82-90 kVDC in High Power Mode | Similar at low kVpDifferent at high kVp |
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| REMEX-Xcam6 (Subject Device) | TR90BH (K182207) | Comparison | |
|---|---|---|---|
| Source to Skin Distance (SSD) | 300 mm | 300 mm | Same |
| Maximum symmetrical Radiation Field | 430.0 mm X 430.0 mm at SID 1,000 mm | 44cm X 44cm @SID 100cm | Similar |
| Accuracy of loading factor | Tube voltage: less than 10%Tube current: less than 20%Time: less than +/-(10%+1ms) | Tube voltage: +/-10%Tube current: +/-20%Time: +/-(10%+1ms) | Same |
| X-ray tube | Canon D-041SB with Modification | Canon D-0814M | Different |
| Focal Spot Size | 0.4mm | 0.8mm | Different |
| Performance Standard | IEC 60601-1:2020IEC 60601-1-2:2020IEC 60601-1-3:2021IEC 60601-1-6:2021IEC 60601-2-28:2017IEC 60601-2-54:2022IEC 62304:2015IEC 62366-1:2020 | IEC 60601-1:2012IEC 60601-1-2:2007IEC 60601-1-3:2008IEC 60601-1-6:2010IEC 60601-2-28:2010IEC 60601-2-54:2009IEC 62304:2006IEC 62366-1:2014 | Similar |
| Compatible X-ray Detector | Trade/Device name: PIXX 1717Manufacturer: PIXXGEN Corporation510(k) Number: K180976 | - | - |
The predicate device, TR90BH, is intended for acquiring X-ray images of the patient's head, abdomen, chest, and extremities, whereas the REMEX Xcam6 is intended for diagnostic imaging of body extremities only. This difference does not materially alter the primary intended use, which is the acquisition of diagnostic X-ray images of extremities.
The REMEX Xcam6 differs from the predicate device in certain design aspects, including physical dimensions, weight, power source, and X-ray tube configuration. These differences reflect design optimizations to enhance portability and do not introduce new questions of safety or effectiveness.
Although there are differences in tube current range and exposure time between the two devices, these parameters have been fully validated through bench testing and clinical image evaluations. The REMEX Xcam6 has also undergone testing and verification for electrical safety, electromagnetic compatibility (EMC), and software performance in accordance with applicable standards.
The results of these evaluations demonstrate that the REMEX Xcam6 is as safe and effective as the predicate device and support a determination of substantial equivalence.
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VII. Summary of Clinical and Non-clinical testing
To establish substantial equivalence, both non-clinical and clinical performance testing were conducted on the REMEX Xcam6. The testing demonstrated that the subject device is as safe and effective as the predicate device and performs as intended.
A summary of the standards followed is provided below:
| Standard | Contents | FDA Rec. standard |
|---|---|---|
| ISO 14971:2019 | Medical devices - Application of risk management to medical devices | 5-125 |
| IEC 60601-1:2005/A2:2020 | Medical electrical equipment Part 1: General requirement for basic safety and essential performance | 19-49 |
| IEC 60601-1-2:2014/A1:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 19-36 |
| IEC 60601-1-3:2008/A2:2021 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 12-336 |
| IEC 60601-1-6:2010/A2:2020 | Medical electrical equipment Part 1-6: General requirements for safety – Collateral standard: Usability | 5-132 |
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | 12-309 |
| IEC 60601-2-54:2022 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 12-348 |
| IEC 62366-1:2015/A1:2020 | Medical devices. Application of usability engineering to medical devices. | 5-129 |
| IEC 62304:2006/A1:2015 | Medical device software - Software life-cycle processes | 13-79 |
| ISO 15223-1:2021 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | 5-134 |
| 21 CFR 1020.30 | Diagnostic x-ray system and their major components | |
| 21 CFR 1020.31 | Radiographic equipment |
• Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) testing were conducted in accordance with applicable international and FDA-recognized standards. The REMEX Xcam6
Page 10
complies with the IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54 standard for safety and IEC 60601-1-2 standard for EMC.
• Image quality and dosimetry bench testing
Bench testing was performed to evaluate image quality and dosimetry using phantoms. The device met all predefined acceptance criteria established in the test protocol. The results confirm that the image quality and radiation dose characteristics of the subject device are substantially equivalent to those of the predicate device.
• Software Verification and Validation Testing
Software verification and validation were performed in accordance with IEC 62304:2006/A1:2015, Medical device software – Software life cycle processes. The REMEX Xcam6 software is classified as Class B under IEC 62304, indicating that a software failure or latent defect could pose a low level of risk, potentially resulting in non-serious injury to the patient, operator, or others. Cybersecurity was addressed per FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
• Clinical Performance Testing
A limited clinical test was conducted to confirm the device's capability to produce diagnostic images of body extremities. The acquired images were reviewed and assessed by a board-certified radiologist, who verified that the device performed successfully and that the image quality was suitable for diagnostic interpretation.
VIII. CONCLUSIONS
A comparison of the intended use and technological characteristics demonstrates that the REMEX Xcam6 is at least as safe and effective as the predicate device. The analysis supports a determination of substantial equivalence between the subject device and the predicate.
Performance data, including bench testing and clinical image evaluations, further support the safety and effectiveness of the REMEX Xcam6. These results confirm that the device performs as intended under the specified use conditions.
Accordingly, the REMEX Xcam6 is considered substantially equivalent to the predicate device, in accordance with the criteria outlined in 21 CFR § 807.92.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.