(181 days)
The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.
The GXR Series Diagnostic X-ray System consists of a combination of an x-ray generator, and associated equipment such as tube stand, patient table, and, digital imaging system.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GXR-series diagnostic x-ray system:
It's important to note that the provided document is a 510(k) Summary, which is a regulatory filing for a medical device seeking clearance from the FDA based on substantial equivalence to a predicate device. It typically focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving absolute performance against specific clinical acceptance criteria in a comprehensive clinical study. Therefore, the details provided often lean towards non-clinical testing and comparison with established standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it relies on demonstrating adherence to recognized safety and performance standards, and comparison of technical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if the device meets these standards and is substantially equivalent to the predicate.
Here's a generalized interpretation based on the document's content, focusing on what would typically be implied performance requirements for an X-ray system:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Electrical, Mechanical, Radiation) | Meets international safety and EMC standards (IEC 60601-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-1-2), and 21CFR 1020.30. "No negative impact on safety or effectiveness" reported for differences. |
| Essential Performance (X-ray Generation Parameters) | Output Power Rating (32kW-82kW), Line Voltage (220-230VAC, 380/400/480VAC) are equivalent or within acceptable ranges of predicate. |
| Image Quality (Digital Diagnostic X-ray System) | "State-of-the-art image quality," "excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch" reported. Non-clinical performance data for new flat panel detectors. |
| Software Functionality (Image Processing, User Interface) | "System imaging software 'RADMAX'" updated GUI for "better visibility & faster workflow." Image Processing Module 4 added; "performance verification...concluded no impact on safety and effectiveness." |
| Usability | Adheres to IEC 60601-1-6 (Usability). Operator control console designed to be "simple and user-friendly." |
| Risk Management | Adheres to ISO 14971 (Risk Management). |
| Software Life Cycle Processes | Adheres to IEC 62304 (Software Life Cycle Processes). |
| Compliance with DICOM and Image Compression Standards | Adheres to NEMA PS 3.1-3.20 (DICOM) and ISO IEC10918-1 (Image Compression). |
| Exposure Index of Digital X-ray Imaging Systems | Adheres to IEC 62494-1 (Exposure Index). |
| Substantial Equivalence to Predicate Device (Overall) | "Substantially equivalent in the areas of technical characteristics, general function, application, and intended use," and "does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" sample size in terms of clinical images or patient cases for performance evaluation against specific acceptance criteria. The testing discussed is primarily non-clinical, related to hardware and software verification and validation.
- Data Provenance: The document implies that the testing data is generated from laboratory testing and verification during the development and modification of the device. There is no mention of clinical data or patient data being used for the performance evaluation in this 510(k) summary. Given the context of a 510(k), particularly for an X-ray system, the primary focus is on engineering and performance testing against standards, rather than large-scale clinical studies. The data is thus likely prospective in terms of being generated specifically for this submission but is non-clinical in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As the evaluation is non-clinical, there is no mention of "ground truth established by experts" in the context of diagnostic performance evaluation. The "ground truth" for non-clinical testing would typically be the expected technical output or adherence to a standard, rather than expert interpretation of images.
4. Adjudication Method for the Test Set
This information is not provided as the testing described and implied is non-clinical and does not involve expert adjudication of diagnostic findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards, not on proving improved reader performance with or without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This is not applicable in the sense of an AI algorithm's standalone performance. The device is a diagnostic X-ray system, which is inherently designed to be used with a human interpreter (a medical professional). While it has image processing software ("RADMAX"), this software enhances images for human diagnosis, not to provide an automated diagnosis itself.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing is adherence to technical specifications and international standards. For example, for radiation output, the ground truth is that the device delivers the specified kVp and mA, and for electrical safety, that it meets the requirements of IEC 60601-1. For image quality, it refers to intrinsic properties like spatial resolution, MTF, and DQE, which are measured objectively, not subjective expert consensus on diagnostic findings.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is an X-ray imaging system, not an AI/ML diagnostic algorithm that requires a training set of medical images in the conventional sense. The "training" for the device would involve calibration and configuration during manufacturing and installation to ensure it meets its technical specifications. The "RADMAX" software has image processing modules, but the document does not suggest these are deep learning models trained on vast datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. If any parameters for the image processing modules are "learned" or optimized, the document does not elaborate on this process or the ground truth used for such optimization.
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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 7, 2025
DRGEM Corporation % Jongseon Park Regulatory Affairs | Engineer 7F, E-B/D Gwangmyeong Techno-Park, 60Haan-ro, GwangMyeong-si, Gyeonggi 14322 SOUTH KOREA
Re: K242019
Trade/Device Name: GXR-series diagnostic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: July 10, 2024 Received: December 3, 2024
Dear Jongseon 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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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
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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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242019
Device Name GXR-Series Diagnostic X-Ray System
Indications for Use (Describe)
The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.
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) |
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510(k) Summary
K242019
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER [21 CFR 807.92(a) (1)]
DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: pjs98@drgem.co.kr TEL: +82-70-4285-3734, FAX: +82-2-869-8567 Contact Person: Mr. Jongseon PARK, Engineer | Regulatory Affairs Date Prepared: June 15, 2024
II. PROPOSED DEVICE INFORMATION [21 CFR 807.92(a) (2)]
| Product Name: | GXR-Series Diagnostic X-Ray System |
|---|---|
| Common Name: | Stationary X-Ray System |
| Classification Name: | Stationary x-ray system |
| Product Code: | KPR |
| Regulation Number: | 892.1680 |
| Associated Product Code: | MQB |
| Regulatory Class: | II |
Available Device Models : (Models: GXR32S, GXR-40S, GX
82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR
XR-52S, GXR-68S, GXR-R-U40S, GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD, FDR Clinica FGXR-32S, FDR Clinica FGXR-40S, FDR Clinica FGXR-52S, FDR Clinica FGXR-68S, FDR Clinica FGXR-82S, FDR Clinica FGXR-C32S, FDR Clinica FGXR-C40S, FDR Clinica FGXR-C52S, FDR Clinica FGXR-U32S, FDR Clinica FGXR-U40S)
III. PREDICATE DEVICES INFORMATION [21 CFR 807.92(a) (3)]
| Product Name: | GXR-series Diagnostic X-Ray System, (Models GXR-S, GXR-SD series) |
|---|---|
| Common Name: | Stationary X-Ray System |
| Classification Name: | Stationary x-ray system |
| 510(k) Number: | K202572 |
| Product Code: | KPR |
| Regulation Number: | 892.1680 |
| Regulatory Class: | II |
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IV. DEVICE DESCRIPTION [21 CFR 807.92(a) (4)]
· Device Features:
· GXR-S/CS/US 'Analog Diagnostic X-ray System'
" GXR-S/CS/US" system provides excellent performance and stable operation while state-of-the-art image quality. The "GXR-S/CS/US" Series High Voltage X-Ray Generator features excellent accuracy, reproducibility, and longterm stability.
Automatic Calibration function of the generator will minimize calibration time and set correct calibration value. Also the control console of "GXR", "GXR-U" series offers graphic waveform and data of x-ray exposure. So, it is not needed to perform the manual calibration procedure with measurement equipment. Naturally, the generator supports Automatic, Semi-auto and Manual Calibration functions. Adaptable calibration function keeps up long-term stability and accuracy by trimming calibration data whenever xray exposed.
The "GXR-C" Series High Voltage X-Ray Generator features excellent accuracy, reproducibility and long-term stability with capacitor assisted general line power supply.
Only 3KVA line power capacity is enough for x-ray generation up to 40KW, and "GXR-C" series provides minimum 100mAs output at maximum output rating without mA sliding down.
Also, maximum interval for full charging is 10 seconds after maximum output x-ray generation. Only 900VA line power capacity is enough for the battery charging, and "GXR-U" series provides same output rating and performances of line-powered generators.
The operator control console is designed in two types to be simple and user-friendly.
The first type features a large graphic LCD panel display and a soft membrane switch to allow easy selection or change of X-ray parameters.
The second type can be easily operated using the Touch function through a large graphic LCD panel display and intuitive GUI configuration.
Remote Diagnosis Software can make report about information of system, user, service and error by the USB connection between PC and control console, and transfer report to manufacturer via internet. So this function enables fast and accurate diagnosis on problems and saves service cost and system downtime. The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features give you controlled exposure factors, automatically optimized for the radiological study selected.
· GXR-SD/CSD/USD 'Digital Diagnostic X-ray System'
"GXR-SD/CSD/USD" system provides excellent performance and stable operation while state-of-the-art image quality.
The "GXR", "GXR-C", "GXR-U" Series High Voltage X-Ray Generator features excellent accuracy, reproducibility and long-term stability.
Automatic Calibration function of the generator will minimize calibration time and set correct calibration value. Also the control console of "GXR", "GXR-U" series offers graphic waveform and data of x-ray exposure. So, it is not needed to perform the manual calibration procedure with measurement equipment. Naturally, the qenerator supports Automatic, Semi-auto and Manual Calibration functions.
Adaptable calibration function keeps up long-term stability and accuracy by trimming calibration data whenever xray exposed.
The "GXR-C" Series High Voltage X-Ray Generator features excellent accuracy, reproducibility and long-term stability with capacitor assisted general line power supply.
Only 3kVA line power capacity is enough for x-ray generation up to 40kW, and "GXR-C" series provides minimum 100mAs output at maximum output rating without mA sliding down.
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Also, maximum interval for full charging is 10 seconds after maximum output x-ray generation.
Only 900VA line power capacity is enough for the battery charging, and "GXR-U" series provides same output rating and performances of line-powered generators.
Remote Diagnosis Software can make report about information of system, user, service and error by transfer report to manufacturer via internet. So this function enables fast and accurate diagnosis on problems and saves service cost and system downtime.
The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features give you controlled exposure factors, automatically optimized for the radiological study selected.
"GXR-SD/CSD/USD" provides state-of-the-art image quality; image processing and user interface; making the system easy to use.
"GXR-SD/CSD/USD" incorporates the digital flat panel detector technology.
Direct radiography via flat panel detector improves your workflow, exam speed and comfort with efficiency. Digital flat panel detector provides excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's preprogrammed exposure technique setting and post image processing for selected study. Also, high resolution grid supplies excellent image quality.
A high performance imaging workstation and "RADMAX" software serves you a convenient interface and easy operation. Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images. Automatic image storage and print with DICOM 3.0 networking capability increases exam throughput and decreases examination time. Remote diagnosis function enables fast and accurate diagnosis on problems and saves service cost and system downtime.
· Device Identification:
The GXR Series Diagnostic X-ray System consists of a combination of an x-ray generator, and associated equipment such as tube stand, patient table, and, digital imaging system.
· Device Characteristics:
Software
The subject device 'GXR-Series Diagnostic X-ray System' use software (including firmware).
[GXR-S, CS, US 'Analog Diagnostic X-ray System'] Its S/W (X-CON) can perform system control such as the collimation size, filter selection, Control of Generator.
[GXR-SD, CSD, USD 'Digital Diagnostic X-ray System'] Its S/W (RADMAX) can perform processing the radiological image acquired from Solid State X-ray Imaging Device.
Both software being used is identical to the predicate device "GXR-series Diagnostic X-ray System", and its LOC (Level of Concern) is 'Moderate'.
Accordingly, this software (X-CON) is based on predicate device 'GXR-S series Diagnostic system.
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Software Level Determination
(Moderate Level of Concern)
The 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.
· Environment of Use:
This "GXR-series Diagnostic X-ray System" is for use by medical professional Facility. To prevent excess radiation exposure to patient and operator from either primary or secondary radiation, this "GXR-Series Diagnostic X-ray System" must be operated and serviced by trained personnel who are familiar with the safety precautions required.
· Brief Written Description of the Device:
The operating principles are as follows.
The irradiation conditions are 40 to 125 (150) kVp at the photographing site, and the tube current is 10 to 400 (500) mA. When X-rays generated under X-ray irradiation conditions enter the X-ray Film or Flat Panel detector, the film or flat panel detects X-rays incident through the incident surface during X-ray irradiation, and finally generates a radiographic image when X-ray irradiation is completed (in case of Digital Diagnostic X-ray System, After Image processing, Digital Image for Diaqnosis has been generated).
V. INDICATION FOR USE [21 CFR 807.92(a) (5)]
The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.
VI. TECHNOLOGICAL CHARACTERISTICS [21 CFR 807.92(a) (6)]
The Subject device 'GXR-Series Diagnostic X-ray System' (Model: GXR-S, GXR-SD series) is based on the Predicate Device (GXR-series, K202572) including the system control, Indication 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 'GXR-SD Series' (K202572). The changes to the predicate 'GXR-SD series' (K202572) include:
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System Imaging Software 'RADMAX'
· Graphical user interface (GUI): GUI of system software updated in order to improve the look and feel of user interface for better visibility & faster workflow.
· Image Processing Module added (Module 4): We conducted performance verification of Flat Panel detectors compared to existing image processing modules. Verification and Validation testing concluded no impact on safety and effectiveness.
Component Change
·10x12 inch Wireless Flat Panel detectors have been added
·Luna1012X manufactured by IRAY Technoloqy, FDA Cleared K221345
·14x17 inch Wireless Flat Panel detectors have been added
·Mars1417X manufactured by IRAY Technology, FDA Cleared K210316 ·A1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930 ·F1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930
·17x17 inch Wireless Flat Panel detectors have been added
·Mars1717X manufactured by IRAY Technology, FDA Cleared K210314 ·A1717MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930
·Patient Table option has been added
· PBT-6 (Deluxe) option manufactured by DRGEM
·Wall Bucky stand option has been added
·WBS (Manual Plus) option manufactured by DRGEM ·WBS-TA (Actuator) option manufactured by DRGEM ·WBS-TA (Deluxe) option manufactured by DRGEM
·Tube Stand option has been added
·TS-CSP (15inch LCD Panel) option manufactured by DRGEM
·Tube Housing Assembly models have been added
·RTM90HS Tube Housing Assembly option manufactured by IAE ·RTM101HS Tube Housing Assembly option manufactured by IAE ·RTC600HS Tube Housing Assembly option manufactured by IAE ·UH-6FC-31E Tube Housing Assembly option manufactured by Fujifilm
·GXR-Series Diagnostic X-ray System's 'Variant models' have been added
: Variant models (FDR Clinica FGXR-S, CS, US) of Subject Device have been added. These models are manufactured for OEM Contractor (Fujifilm Corporation).
Difference between predicate device (GXR-S, CS, US 'Analog Diagnostic X-ray
System') and OEM Model (FDR Clinica FGXR-S, CS, US) has only label, exterior color, model name.
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Image /page/9/Picture/0 description: The image is a logo for DRGEM, a healthcare provider. The logo features the text "DRGEM" in a bold, sans-serif font, with "DR" in black and "GEM" in teal. Below the company name is the tagline "Your Best Healthcare" in a smaller, lighter font.
Substantial Equivalence Comparison
VII.SUBSTANTIAL EQUIVALENCE [21 CFR 807.92(b)]
Substantial Equivalence Comparison Table
| Item | Subject Device | Predicate Device | Impact of Differences | |||
|---|---|---|---|---|---|---|
| Device Name | GXR-SeriesDiagnostic X-ray System | GXR-SeriesDiagnostic X-ray System | Same | |||
| 510(k) number | K242019 | K202572 | - | |||
| Indication for use | The GXR-Series Diagnostic X-ray System is intendedfor use in obtaining human anatomical images formedical diagnostic by using X-rays. | GXR-Series Diagnostic X-raySystem is a stationary X-rayimaging system, for thepurpose of acquiring X-rayimages of the desired parts ofa patient's anatomy. Thisdevice is not intended formammography or bonedensity applications. | Both devices arefundamentally intended toacquire anatomical images ofpatients for medicaldiagnostic purposes.This means they essentiallyshare the same indication foruse. Some contentsmentioned in the predicatedevice's Indication for use aredescribed in theIFU(operationManual)_Contraindicationsection of the subject device. | |||
| Manufacturer | DRGEM Corporation | DRGEM Corporation | Same | |||
| Analog DiagnosticX-ray System | Digital DiagnosticX-ray System | AnalogDiagnosticX-ray System | DigitalDiagnosticX-ray System | |||
| DRGEM | Fujifilm | DRGEM | DRGEM | DRGEM | Variant models (FDR ClinicaFGXR-S, CS, US) of SubjectDevice have been added. | |
| ModelName | •GXR-32S | •FDR ClinicaFGXR-32S | •GXR-32SD | •GXR-32S | •GXR-32SD | These models aremanufactured for OEMContractor (FujifilmCorporation). |
| •GXR-40S | •FDR ClinicaFGXR-40S | •GXR-40SD | •GXR-40S | •GXR-40SD | Difference between predicatedevice (GXR-S, CS, US'Analog Diagnostic X-raySystem') and OEM Model(FDR Clinica FGXR-S, CS,US) has only label, exteriorcolor.All Specification is same aspredicate device (GXR-S, CS,US). | |
| •GXR-52S | •FDR ClinicaFGXR-52S | •GXR-52SD | •GXR-52S | •GXR-52SD | ||
| •GXR-68S | •FDR ClinicaFGXR-68S | •GXR-68SD | •GXR-68S | •GXR-68SD | ||
| •GXR-82S | •FDR ClinicaFGXR-82S | •GXR-82SD | •GXR-82S | •GXR-82SD | ||
| •GXR-C32S | •FDR ClinicaFGXR-C32S | •GXR-C32SD | •GXR-C32S | •GXR-C32SD | ||
| •GXR-C40S | •FDR ClinicaFGXR-C40S | •GXR-C40SD | •GXR-C40S | •GXR-C40SD | ||
| •GXR-C52S | •FDR ClinicaFGXR-C52S | •GXR-C52SD | •GXR-C52S | •GXR-C52SD | ||
| •GXR-U32S | •FDR ClinicaFGXR-U32S | •GXR-U32SD | •GXR-U32S | •GXR-U32SD | ||
| •GXR-U40S | •FDR ClinicaFGXR-U40S | •GXR-U40SD | •GXR-U40S | •GXR-U40SD |
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Image /page/10/Picture/0 description: The image shows the logo for DRGEM. The letters "DR" are in black, and the letters "GEM" are in teal. Below the logo is the text "Your Best Healthcare" in a smaller font.
| 1. High Frequency X-ray Generator | ||||
|---|---|---|---|---|
| Output Power Rating (kW) | 32kW, 40kW, 52kW, 68kW, 82kW | 32kW, 40kW, 52kW, 68kW, 82kW | ||
| Generator models (manufactured by DRGEM) | •GXR-32 | •GXR-32 | ||
| •GXR-40 | •GXR-40 | |||
| •GXR-52 | •GXR-52 | |||
| •GXR-68 | •GXR-68 | |||
| •GXR-82 | •GXR-82 | |||
| •GXR-C32 | •GXR-C32 | |||
| •GXR-C40 | •GXR-C40 | |||
| •GXR-C52 | •GXR-C52 | |||
| •GXR-U32 | •GXR-U32 | |||
| •GXR-U40 | •GXR-U40 | |||
| Line voltage | 220~230VAC380/400/480VAC | 220~230VAC380/400/480VAC | ||
| 2. Solid State X-ray Imaging Device (Digital Diagnostic X-ray System Only) | ||||
| Flat panel Detector | •PaxScan4343R v3 / VAREX | •PaxScan4343R v3 / VAREX | Additional Solid State X-rayImage detectors from thepredicate can be used withthe system. The system hasbeen tested and there is "Nonegative impact on safety oreffectiveness".And also, All modified flatpanel detector have beenverified according to "SSXInon-clinical performancedata"There is no new potential orincreased safety risksconcerning were raisedbecause of this difference. | |
| •PaxScan4343RC / VAREX | •PaxScan4343RC / VAREX | |||
| •PaxScan4336W v4 / VAREX | •PaxScan4336W v4 / VAREX | |||
| •4343W (Basic) / VAREX | •4343W / VAREX | |||
| •XRpad2 3025 HWC-M / VAREX | •XRpad2 3025 HWC-M / VAREX | |||
| •XRpad2 4343 HWC-M / VAREX | •XRpad2 4343 HWC-M / VAREX | |||
| •XRpad2 4336 HWC-M / VAREX | •XRpad2 4336 HWC-M / VAREX | |||
| •Mano4343T / IRAY | •Mano4343T / IRAY | |||
| •Mano4343X / IRAY | •Mano4343X / IRAY | |||
| •Mano4336W / IRAY | •Mano4336W / IRAY | |||
| •Mano4343W / IRAY | •Mano4343W / IRAY | |||
| •Mars1417X / IRAY | •VIVIX-S1417N / VIEWWORKS | |||
| •Mars1717X / IRAY | •VIVIX-S1717N / VIEWWORKS | |||
| •Luna1012X / IRAY | ||||
| •A1417MCW / H&abyz | ||||
| A1717MCW / H&abyz | ||||
| F1417MCW / H&abyz | ||||
| 3. Patient table | ||||
| PBT-4 (Motorized) | PBT-4 (Motorized) | Yes, there is a difference. Models have been tested against International Safety and EMC Standards. Any differences between the subject device and predicate device do not change or add new potential safety risks. It is our determination that there is "No negative impact on safety or effectiveness" and there are no new potential or increased safety risks concerning this difference | ||
| PBT-6 (Motorized) | PBT-6 (Motorized) | |||
| PBT-6 (Deluxe) | PBT-1 | |||
| Table Top | Longitudinal | $1,100(\pm550)mm \pm10mm$ | ||
| $840(\pm420)mm \pm10mm$ | ||||
| $640(\pm320)mm \pm10mm$ | ||||
| Transverse (Later a) | $350(\pm150)mm \pm10mm$ | |||
| Configuration model | Vertical | Travel | $350(510\sim860)mm \pm5mm$ | |
| Speed | 13~19mm/sec±10%(Full load to no load) | |||
| Operating | Motorized movement by foot/Hand grip Switch Linear Actuator | |||
| Bucky | Mechanical | •740mm(±10)mm with standard tray•500mm(±10)mm with rotating tray | ||
| Table Tracking | •710mm(±10)mm with standard tray(automatically move only) | |||
| PBT-1 | ||||
| PDT-1 | ||||
| 4. Wall Bucky stand | ||||
| WBS (Manual) | WBS (Manual) | Yes, there is a difference. Models have been tested against International Safety and EMC Standards. Any differences between the subject device and predicate device do not change or add new potential safety risks. It is our determination that there is "No negative impact on safety or effectiveness" and there are no new potential or increased safety risks concerning this difference | ||
| WBS-TM (Manual) | WBS-TM (Manual) | |||
| WBS (Manual Plus) | WBS (Motorized) | |||
| Cassette stroke | 1,220mm (300 | |||
| Electrical Rating | 100-240VAC, 160VA, 50/60Hz | |||
| Configuration model | Dimension/ Weight | 1,749(H) x 659(W) x 445(D) mm / 113kg(249lbs)1,919(H) x 659(W) x 445(D) mm / 116kg(255lbs)2,169(H) x 659(W) x 445(D) mm / 120kg(264lbs) | ||
| WBS (Motorized) | WBS-TM (Motorized) | |||
| WBS-TM (Motorized) | WBS-TA (Motorized) | |||
| WBS-TA (Motorized) | ||||
| WBS-TA (Actuator) | ||||
| Cassette stroke | 1,526mm (283~1,809mm from floor to Bucky center)±10mm |
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Image /page/11/Picture/0 description: The image contains the logo for DRGEM, a healthcare provider. The text "DRGEM" is displayed in bold, with "DR" in black and "GEM" in teal. Below the logo, the tagline "Your Best Healthcare" is written in a smaller, lighter font.
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Image /page/12/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The logo features the company name in bold, with "DR" in black and "GEM" in teal. Below the company name is the tagline "Your Best Healthcare" in a smaller, lighter font. The overall design is clean and professional, conveying a sense of trust and reliability.
| 1,526mm (450~1,976mm from floor to Bucky surface)±10mm | |||
|---|---|---|---|
| Tilting Range -20°~90 | |||
| Tilting Speed | Up 8.2°/s | ||
| down 5.1°/s | |||
| WBS-TA (Deluxe) | |||
| 1,566mm (283~1,849mm from floor to Bucky center)±10mm Cassette stroke | |||
| 1,566mm (591~2,157mm from floor to Bucky surface)±10mm | |||
| Tilting Range -20°~90 | |||
| Tilting Speed | Up 8.2°/s | ||
| down 5.1°/s | |||
| Vertical Speed | Normal 6.2 cm/s ± 15% (Up),5.6cm/s ± 15% (Down) | ||
| Fast 12.1cm/s ± 15% (Up),11.8cm/s ± 15% (Down) | |||
| 5. Tube stand | |||
| Configuration model | TS-FM6 (Motorized) | TS-FM6 (Motorized) | |
| TS-FC6 (Motorized) | TS-FC6 (Motorized) | ||
| TS-FC4 (Motorized) | TS-FC4 (Motorized) | ||
| TS-FC2 (Motorized) | TS-FC2 (Motorized) | ||
| TS-FM6 (Manual) | TS-FM6 (Manual) | ||
| TS-FC6 (Manual) | TS-FC6 (Manual) | ||
| TS-FC4 (Manual) | TS-FC4 (Manual) | ||
| TS-FC2 (Manual) | TS-FC2 (Manual) | ||
| TS-CSA (Manual, Motorized) | TS-CSA (Manual, Motorized) | ||
| TS-CSP (Manual, Motorized) /(7inch,15inch LCD panel) | TS-CSP (Manual, Motorized) /(7inch LCD panel) | ||
| TS-CSE (Manual) | TS-CSE (Manual) | ||
| Tube Rotation Angle | ±135°, ±180° | ±135°, ±180° | |
| 6. X-ray tube housing Assembly | |||
| Configuration model | E7239X | E7239X | |
| DXT-8M | DXT-8M | ||
| E7242X | E7242X | ||
| DXT-11M | DXT-11M | ||
| E7843X | E7843X | ||
| DXT-10M | DXT-10M | ||
| E7876X | E7876X | ||
| E7884X | E7884X | ||
| DXT-12M | DXT-12M | ||
| E7252X | E7252X | ||
| DXT-14U | DXT-14U | ||
| RAD-14 | RAD-14 | ||
| DXT-15U | DXT-15U | ||
| -RAD-21 | -RAD-21 | ||
| -RAD-60 | -RAD-60 | ||
| -RAD-92 | -RAD-92 | ||
| -E7255FX | -E7255FX | ||
| -E7254FX | -E7254FX | ||
| -E7869X | -E7869X | ||
| -RTM90HS | |||
| -RTM101HS | |||
| -RTC600HS | |||
| -UH-6FC-31E | |||
| Max. kV | 125kV, 150kV | 125kV, 150kV | |
| 7. Collimator (Beam Limiting Device) | Yes, there is a difference. | ||
| -R108 | -R108 | Collimator Configuration | |
| -DXC-RML | -DXC-RML, DXC-RMH | Models have been partiallydeleted based on predicate | |
| Configurationmodel | -R302MLP/A | -R302A, R302MLP/A, | device. |
| R302MFMLP/A | It is our determination that | ||
| -MCR | there is "No negativeimpact on safety or | ||
| Lamp Type | LED lamp(Over 160LUX at 100cm SID) | LED and Halogen lamp(Over 160LUX at 100cm SID) | effectiveness" and there |
| are no new potential | |||
| ElectricalRating | 3VDC (1.5 V Battery x 4ea), 3mA | or increased safety risksconcerning this difference | |
| 8. Image Processing and Storage (Digital Diagnostic X-ray System Only) | |||
| Configurationmodel | RADMAX | RADMAX | same |
| FDA Cleared | -- | K182537 | - |
| SoftwareVersion | RADMAX 1.02 V | RADMAX 1.01 V | - see below difference |
| Horizontal Flip | Yes | Yes | same |
| Vertical Flip | Yes | Yes | same |
| RotateCW/CCW | Yes | Yes | same |
| TextAnnotation | Yes | Yes | same |
| Ruler:Distance too | Yes | Yes | same |
| Anglemeasurementtool | Yes | Yes | same |
| Zoom | Yes | Yes | same |
| Magnify | Yes | Yes | same |
| Image panning | Yes | Yes | same |
| Auto fitting towindow size | Yes | Yes | same |
| Image crop/cut | Yes | Yes | same |
| Image Copy | Yes | Yes | same |
| Recover theoriginal image | Yes | Yes | same |
| CD Burning | |||
| DICOM Print | Yes | Yes | same |
| ImageStitching | Yes | Yes | same |
| ImageProcessingModule | • MODULE 1Edge Enhancement: 0 ~ 50Contrast Factor : 1 ~ 200Image Frequency : 0 ~ 20Image Latitude : -10 ~ 10Sharpness : 0 ~ 100• MODULE 2Histogram Optimization : -100 ~ 100Skin line Weight : -100 ~ 100Latitude Compression : -100 ~ 100Contrast Enhancement : -100 ~ 100Edge Enhancement : -100 ~ 100Noise Suppression : -100 ~ 100Gamma : -20 ~ 20• MODULE 3Global Brightness : -100 ~ 100Global Contrast : -100 ~ 100Latitude Compression : -100 ~ 100S-Structure Enhancement : -100 ~ 100Noise Suppression : -100 ~ 100Gamma : -20 ~ 20• MODULE 4Global Contrast : -30 ~ 30Global Brightness : -20 ~ 20Local Contrast : 0 ~ 20Small Enhancement : 0 ~ 20Latitude Reduction : -20 ~ 20Noise Suppression : 0 ~ 20Gamma : -20 ~ 20 | • MODULE 1Edge Enhancement: 0 ~ 50Contrast Factor : 1 ~ 200Image Frequency : 0 ~ 20Image Latitude : -10 ~ 10Sharpness : 0 ~ 100• MODULE 2Histogram Optimization : -100 ~ 100Skin line Weight : -100 ~ 100Latitude Compression : -100 ~ 100Contrast Enhancement : -100 ~ 100Edge Enhancement : -100 ~ 100Noise Suppression : -100 ~ 100Gamma : -20 ~ 20• MODULE 3Global Brightness : -100 ~ 100Global Contrast : -100 ~ 100Latitude Compression : -100 ~ 100S-Structure Enhancement : -100 ~ 100Noise Suppression : -100 ~ 100Gamma : -20 ~ 20 | Yes, there is a difference.Models have beenconducted Verificationactivity. Any differencesbetween the subject deviceand predicate device donot change or add newpotential safety risks. It isour determination thatthere is "No negativeimpact on safety oreffectiveness" and thereare no new potentialor increased safety risksconcerning this difference |
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Image /page/13/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The letters "DR" are in bold, black font, while "GEM" is in a teal color. Below the company name is the slogan "Your Best Healthcare" in a smaller font.
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Image /page/14/Picture/0 description: The image contains the logo for DRGEM. The logo has the letters "DR" in black and the letters "GEM" in teal. Below the logo is the text "Your Best Healthcare" in a smaller font.
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Image /page/15/Picture/0 description: The image is a logo for DRGEM, a healthcare company. The logo features the text "DRGEM" in a bold, sans-serif font, with "DR" in black and "GEM" in teal. Below the company name is the tagline "Your Best Healthcare" in a smaller, lighter font.
VIII. SUMMARY OF NON-CLINICAL Data [21 CFR 807.92(b) (1)]
Nonclinical Testing:
The GXR-Series Diagnostic X-Ray System, has been assessed and tested and has passed predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the subject device 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.
| Std # | Safety/EMC Standards Description | FDA Rec.Standard # |
|---|---|---|
| IEC 60601-1-3 | Medical electrical equipmentPart 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment | 12-336 |
| IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10Medical electrical equipment - Part 1-6: General requirements for basic safety andessential performance - Collateral standard: Usability | 5-132 |
| IEC 60601-2-28 | IEC 60601-2-28Medical electrical equipment Part 2: Particular requirements for the safety of X-ray sourceassemblies and X-ray tube assemblies for medical diagnosis | 12-309 |
| IEC 60601-2-54 | IEC 60601-2-54Medical electrical equipmentPart 2: Particular requirements for the basic safety and essential performanceof X-ray equipment for radiography and radioscopy | 12-348 |
| IEC 60601-1-2(EMC) | IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance - Collateral Standard:Electromagnetic disturbances Requirements and tests. | 19-36 |
| IEC 62304:2006 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSIONMedical device software - Software life cycle processes | 13-79 |
| IEC 60601-1 | Medical electrical equipment, Part 1: General requirements for basic safety and essentialperformance | 19-46 |
| ISO 14971:2019 | ISO 14971:2019 Third Edition, Medical devices - Applications of risk management tomedical devices. | 5-125 |
| ISO 15223-1 | ISO 15223-1 Fourth Edition 2021-07, Medical devices - Symbols to be used with medicaldevice labels, labelling, and information to be supplied - Part 1: General requirements. | 5-134 |
| IEC 62366-1 | 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1:Application of usability engineering to medical devices | 5-129 |
| TR 60601-4-2 | TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: performance of medical electrical equipment andmedical electrical systems | 19-19 |
| NEMA PS 3.1-3.20 (2022) | Digital Imaging and Communications in Medicine (DICOM) Set | 12-349 |
| ISO IEC10918-1 | ISO IEC10918-1 First edition 1994-02-15 Information technology - Digital compression andcoding of continuous-tone still images: Requirements and guidelines [Including: TechnicalCorrigendum 1 (2005)] | 12-261 |
| IEC 62494-1 | IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment- Exposure index of digitalX-ray imaging systems - part 1: Definitions and requirements for general radiography | 12-215 |
| FDA Guidance | Pediatric Information for X-ray Imaging Device Premarket Notifications dated November 28, 2017 | |
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s, Guidance for Industry and Food and Drug AdministrationStaff, Document issued on September 13, 2019. | |
| FDA Guidance | Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices dated September 1, 2016 | |
| FDA Guidance | Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Softwarecontained in Medical Devices, Document issued on: May 11, 2005 Medical Devices, Document issued on:May 11, 2005 | |
| FDA Guidance | Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food andDrug Administration Staff Document issued on June 14, 2023. | |
| FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsGuidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023. |
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Image /page/16/Picture/0 description: The image contains the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the logo, the text "Your Best Healthcare" is written in a smaller, lighter font.
Summary:
Based on the performance as documented in the V&V Testinq, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device. The following International Standards were used to develop and verify electrical safety, and EMC. GXR-Series Diagnostic X-Ray System has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports).
The subject device conform to all applicable aspects of 21CFR 1020.30.
IX. CONCLUSIONS [21 CFR 807.92(b) (3)]
The 510(k) Pre-Market Notification for GXR-series Diagnostic X-ray System, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and the predicate device 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 comparably to the predicate devices.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.