(20 days)
No
The summary describes standard digital radiography components and image processing techniques like anatomical view-based optimization, but does not mention AI, ML, or related terms.
No
The device is described as a "Diagnostic X-Ray System" used for "acquiring X-ray images" and "to diagnose the human body." It does not mention any therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states "GXR-Series Diagnostic X-Ray System, is a stationary X-ray imaging system, for the purpose of acquiring X-ray images...". Additionally, the "Device Description" states, "The subject device, GXR Series Diaqnostic X-ray System, is designed to diagnose the human body by providing radiographic x-ray image with anatomical structure."
No
The device description explicitly lists numerous hardware components including a high voltage generator, tube support unit, X-ray beam limiting device, patient table, wall Bucky stand, X-ray tube, operator control console, and digital flat panel detectors. While it includes imaging software, it is part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "acquiring X-ray images of the desired parts of a patient's anatomy" for the purpose of "diagnose the human body by providing radiographic x-ray image with anatomical structure." This describes an in-vivo imaging system, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
- Device Description: The description details components like an X-ray tube, patient table, and wall Bucky stand, all of which are characteristic of an in-vivo X-ray system used on a living patient.
- No mention of in-vitro testing: There is no mention of analyzing blood, tissue, or any other biological samples outside of the body.
Therefore, the GXR-Series Diagnostic X-Ray System is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
GXR-Series Diagnostic X-Ray System, is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
Product codes
KPR
Device Description
GXR Series Diagnostic X-ray System is a digital radiographic system. There are 5 power output configurations which are reflected in the model's designation "GXR-XX" The models have 5 different output power ratings: GXR-32SD (32kW), GXR-40SD (40kW), GXR-52SD (52kW), GXR-68SD (68kW), GXR-82SD (82kW).
The subject device, GXR Series Diaqnostic X-ray System, is designed to diagnose the human body by providing radiographic x-ray image with anatomical structure.
The subject device has the same x-ray hardware components and image management software as the predicate device. The subject device consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a patient table, wall Bucky stand, and an x-ray tube, that operates on a high-frequency inverter method.
The operator control console is designed to be user-friendly, and the user can select or change x-ray parameters easily using a large graphic LCD panel display and a soft membrane switch. The GXR Series high frequency X-ray generator (manufactured by DRGEM) features accuracy, reproducibility and long-term stability with capacitor assisted general line power supply. The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features gives the user control of exposure factors, automatically optimized for the radiological study selected.
The digital flat panel detectors provide 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 pre-programmed exposure technique setting and post image processing for selected study. The subject device is able to use a total of 10 different digital detectors, (8 new plus 2 cleared in the predicate, which have been previously cleared by the 510(k) process:
- VAREX, 4343R v3 K172951(predicate)
- VAREX, 4336W v4- K161459 (predicate)
- VAREX, XRpad2 3025 HWC-M- K161942
- VAREX, XRpad2 4336 HWC-M- K161966
- VAREX, XRpad2 4343 HWC-M- K181526
- i-Ray, Mano4336W- K201004
- i-Ray, Mano4343W- K201043
- Vieworks, VIVIX-S1417N(NAW,NBW)-K163703
- Vieworks, VIVIX-S1717N(NAW,NBW)- K152894
- VAREX, 4343W- K161459
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. The main power cabinet contains the HT tank and control circuits, the filament drivers, the low speed starter, and interface connections to the room equipment.
- Tube stand and patient table allows the operator to position the patient.
- Full Featured Imaging Software & Digital Image Processing
- Control console:
- The control console allows the operator to select the technique factors, O image receptors, etc., and to initiate an X-ray exposure.
- Real-time monitoring self-diagnosis function and Error code display o
- o Overload & HU protection and error message display
- o Support programmable max. 1,280 APR conditions with APR utility software
- Automatic calibration without measurement equipment. o
- Adaptable calibration keeps up accuracy through long-term usage o
- Smaller, lighter and convenient modular design and user-friendly system O configuration
- O Constant dose output due to kV and mA requlation during exposures.
- Large graphic LCD panel user-friendly controls for APR and technique o display at a glance,
- Time and mA / mAs selections are based on R'10 rule of ISO 497. o
- Remote diagnosis software for system diagnosis via internet. O
- o Easy parameter setting and Firmware upgrade
- System diagnosis, Error log and Statistical data display O
The image manaqement software, RADMAX Digital Imaging Software (K182537) by DRGEM, is used in both the predicate and subject device to serve as a convenient interface to the hardware and images. Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images. RADMAX (K182537) Digital Imaging Software is designed for acquiring images and processing the acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the RADMAX software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. It can also perform system control such as the collimation size, and filter selection. The following are general features.
- Windows based graphic user interface
- Multi-image display (1x1 ~ 4x4)
- Multi-image selection
- Auto display layout changing function
- X-ray generator control panel
- Unlimited procedure step
- Quick step-add feature and image maintenance feature by popup menu
- ROI changing and creation feature
- Marker feature (support the creation of unlimited number of markers by user)
- Multi-language support
- EXCEL sheet for language support (only possible on Microsoft Office automation environment)
- DAP meter (optional)
- Unlimited PACS code (CPT code)
- Default anatomic program more than 700
- Support DICOM Worklist SCU, DICOM Storage SCU and transfer function
- Support DICOM Multi-transfer function
- High-performance post-processing feature
- Copy & Move Images
- Dose monitoring function
- Built-in memory function
- Grid line suppression function
- Reject analysis function
Mentions image processing
Yes, "Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images." and "RADMAX (K182537) Digital Imaging Software is designed for acquiring images and processing the acquired images."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Desired parts of a patient's anatomy.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
Based on the performance as documented in the testing, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device.
The complete system has been assessed and tested at the factory and by Standards testing facilities. GXR-Series Diagnostic X-Ray System, has passed all predetermined testing criteria. 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.
The following International Standards were used to develop and verify the system. GXR-Series Diagnostic X-Ray System, device has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):
- IEC 60601-1: Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-3: Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
- IEC 62366: This part of IEC 62366-1:2015 specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety
- IEC 60601-2-28: Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis.
- 60601-2-54: Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 60601-1-2 (EMC): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances Requirements and tests.
- IEC 62304: Medical device software - Software life cycle processes
- NEMA PS 3.1: NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard.
- IEC/ISO10918-1: JPEG Standard IEC/ISO10918-1 First edition 1994-02-15, Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1
- IEC 62494-1: Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography.
- ISO 14971:: ISO 14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices - Applications of risk management to medical devices.
- ISO 15223-1: ISO 15223-1 Third Edition 2016-11-01, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K172951, K161459, K161942, K161966, K181526, K201004, K201043, K163703, K152894, K161459, K182537
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
September 24, 2020
Image /page/0/Picture/1 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.
DRGEM Corporation % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K202572
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 Dated: August 27, 2020 Received: September 4, 2020
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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-regulatoryassistance/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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202572
Device Name GXR-Series Diagnostic X-Ray System
Indications for Use (Describe)
GXR-Series Diagnostic X-Ray System, is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
| 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."
3
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: September 18, 2020
I. SUBMITTER
DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr
Contact Person: Mr. Ki-Nam YANG, Director | QM representative
II. DEVICE
| Product Name: | GXR-Series Diagnostic X-Ray System |
|---|---|
| Common Name: | Digital Diagnostic X-ray System |
| Regulation Name: | Stationary X-Ray System |
| Product Code: | KPR |
| Regulation number: | 892.1680 |
| Regulatory Class: | II |
III. PREDICATE DEVICE
| Product Name: | GXR-Series Diagnostic X-Ray System |
|---|---|
| Submission Number: | K192364 |
| Decision Date: | 09/26/2019 |
| Common Name: | Digital Diagnostic X-ray System |
| Regulation Name: | Stationary X-Ray System |
| Product Code: | KPR |
| Regulation Number: | 892.1680 |
| Regulatory Class: | II |
IV. DEVICE DESCRIPTION
GXR Series Diagnostic X-ray System is a digital radiographic system. There are 5 power output configurations which are reflected in the model's designation "GXR-XX" The models have 5 different output power ratings:
| DRGEM System
| Model | GXR-32SD | GXR-40SD | GXR-52SD | GXR-68SD | GXR-82SD |
|---|---|---|---|---|---|
| DRGEM | |||||
| Generator Model | GXR-32 | GXR-40 | GXR-52 | GXR-68 | GXR-82 |
| Generator | |||||
| Output Rating | 32kW | 40kW | 52kW | 68kW | 82kW |
The subject device, GXR Series Diaqnostic X-ray System, is designed to diagnose the human body by providing radiographic x-ray image with anatomical structure.
The subject device has the same x-ray hardware components and image management software as the predicate device. The subject device consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a patient table, wall Bucky stand, and an x-ray tube, that operates on a high-frequency inverter method.
The operator control console is designed to be user-friendly, and the user can select or change x-ray parameters easily using a large graphic LCD panel display and a soft membrane switch. The GXR Series high frequency X-ray generator (manufactured by
4
DRGEM) features accuracy, reproducibility and long-term stability with capacitor assisted general line power supply. The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features gives the user control of exposure factors, automatically optimized for the radiological study selected.
The digital flat panel detectors provide 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 pre-programmed exposure technique setting and post image processing for selected study. The subject device is able to use a total of 10 different digital detectors, (8 new plus 2 cleared in the predicate, which have been previously cleared by the 510(k) process:
- VAREX, 4343R v3 K172951(predicate) ●
- VAREX, 4336W v4- K161459 (predicate) .
- . VAREX, XRpad2 3025 HWC-M- K161942
- VAREX, XRpad2 4336 HWC-M- K161966 .
- VAREX, XRpad2 4343 HWC-M- K181526 ●
- i-Ray, Mano4336W- K201004 ●
- . i-Ray, Mano4343W- K201043
- . Vieworks, VIVIX-S1417N(NAW,NBW)-K163703
- Vieworks, VIVIX-S1717N(NAW,NBW)- K152894 ●
- VAREX, 4343W- K161459 .
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. The main power cabinet contains the HT tank and control circuits, the filament drivers, the low speed starter, and interface connections to the room equipment.
- . Tube stand and patient table allows the operator to position the patient.
- Full Featured Imaging Software & Digital Image Processing .
- Control console: .
- The control console allows the operator to select the technique factors, O image receptors, etc., and to initiate an X-ray exposure.
- Real-time monitoring self-diagnosis function and Error code display o
- o Overload & HU protection and error message display
- o Support programmable max. 1,280 APR conditions with APR utility software
- Automatic calibration without measurement equipment. o
- Adaptable calibration keeps up accuracy through long-term usage o
- Smaller, lighter and convenient modular design and user-friendly system O configuration
- O Constant dose output due to kV and mA requlation during exposures.
- Large graphic LCD panel user-friendly controls for APR and technique o display at a glance,
- Time and mA / mAs selections are based on R'10 rule of ISO 497. o
- Remote diagnosis software for system diagnosis via internet. O
- o Easy parameter setting and Firmware upgrade
- System diagnosis, Error log and Statistical data display O
The image manaqement software, RADMAX Digital Imaging Software (K182537) by DRGEM, is used in both the predicate and subject device to serve as a convenient interface to the hardware and images. Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images. RADMAX
5
(K182537) Digital Imaging Software is designed for acquiring images and processing the acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the RADMAX software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. It can also perform system control such as the collimation size, and filter selection. The following are general features.
- . Windows based graphic user interface
- Multi-image display (1x1 ~ 4x4) ●
- Multi-image selection ●
- . Auto display layout changing function
- . X-ray generator control panel
- . Unlimited procedure step
- Quick step-add feature and image maintenance feature by popup menu ●
- ROI changing and creation feature ●
- Marker feature (support the creation of unlimited number of markers by user) ●
- Multi-language support .
- EXCEL sheet for language support (only possible on Microsoft Office automation ● environment)
- . DAP meter (optional)
- . Unlimited PACS code (CPT code)
- Default anatomic program more than 700
- Support DICOM Worklist SCU, DICOM Storage SCU and transfer function
- . Support DICOM Multi-transfer function
- High-performance post-processing feature ●
- Copy & Move Images
- Dose monitoring function ●
- Built-in memory function ●
- Grid line suppression function .
- . Reject analysis function
V. INDICATIONS FOR USE
GXR-Series Diagnostic X-Ray System, is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Summary of differences:
The subject device can interface to one of eight previously cleared digital flat panel detectors in addition to the 2 detectors used in the predicate device as listed above.
- . VAREX, 4343R v3 - K172951(predicate)
- VAREX, 4336W v4- K161459 (predicate) .
- VAREX, XRpad2 3025 HWC-M- K161942 .
- . VAREX, XRpad2 4336 HWC-M- K161966
- . VAREX, XRpad2 4343 HWC-M- K181526
- . i-Ray, Mano4336W- K201004
6
- i-Ray, Mano4343W- K201043 .
- . Vieworks, VIVIX-S1417N(NAW,NBW)-K163703
- Vieworks, VIVIX-S1717N(NAW,NBW)- K152894 ●
- . VAREX, 4343W- K161459
The following information compares the subject device to the predicate.
Any differences between the subject device and the predicated device have no negative impact on safety or efficacy of the subject device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
| Specification | Predicate device K192364 | Subject Device | Impact of Differences |
|---|---|---|---|
| Device Name | GXR-Series Diagnostic | ||
| Imaging System | GXR-Series Diagnostic | ||
| Imaging System | None | ||
| Manufacturer | DRGEM Corporation | DRGEM Corporation | None |
| Model Number | GXR-SD/CSD/USD | GXR-SD/CSD/USD | None |
| High Frequency X- | |||
| ray Generator | |||
| Output Power | 32KW, 40KW, 52KW, 68KW, | ||
| 82KW | 32KW, 40KW, 52KW, | ||
| 68KW, 82KW | None | ||
| Generator models | |||
| (manufactured by | |||
| DRGEM) | GXR-32, GXR-40, GXR-52, | ||
| GXR-68, GXR-82 | |||
| GXR-C32, GXR-C40, GXR- | |||
| C52 | GXR-32, GXR-40, GXR- | ||
| 52, GXR-68, GXR-82 | |||
| GXR-C32, GXR-C40, | |||
| GXR-C52 | None | ||
| Line voltage | 220~230VAC | ||
| 380/400/480VAC | 220~230VAC | ||
| 380/400/480VAC | None | ||
| kV Range | 40~125kV, 1kV step (Optional | ||
| 40~150kV) | 40~125kV, 1kV step | ||
| (Optional 40~150kV) | None | ||
| mA Range | GXR-32-10 to 400mA | ||
| GXR-40-10 to 500mA | |||
| GXR-52-10 to 640mA | |||
| GXR-68-10 to 800mA | |||
| GXR-82-10 to 1,000mA | GXR-32-10 to 400mA | ||
| GXR-40-10 to 500mA | |||
| GXR-52-10 to 640mA | |||
| GXR-68-10 to 800mA | |||
| GXR-82-10 to 1,000mA | None | ||
| Image Acquisition | |||
| Detectors | VAREX, 4343R v3 - K172951 | ||
| VAREX, 4336W v4- K161459 | VAREX, 4343R v3 - | ||
| K172951 | |||
| VAREX, 4336W v4- | |||
| K161459 | |||
| VAREX, XRpad2 3025 | |||
| HWC-M- K161942 | |||
| VAREX, XRpad2 4336 | |||
| HWC-M- K161966 | |||
| VAREX, XRpad2 4343 | |||
| HWC-M- K181526 | |||
| i-Ray, Mano4336W- | |||
| K201004 | |||
| i-Ray, Mano4343W- | |||
| K201043 | |||
| Vieworks, VIVIX-S1417N | |||
| (NAW, NBW)-K163703 | |||
| Vieworks, VIVIX-S1717N | |||
| (NAW, NBW)- K152894 | |||
| VAREX, 4343W- K161459 | Yes, there is a difference. | ||
| An additional eight digital | |||
| detectors plus the two from | |||
| the predicate can be used | |||
| with the system. All the flat | |||
| panel detectors have been | |||
| previously cleared by | |||
| 510(k). The system has | |||
| been tested and a risk | |||
| analysis performed. There is | |||
| "No negative impact on | |||
| safety or efficacy" and no | |||
| new potential or increased | |||
| safety risks concerning were | |||
| raised because of this | |||
| difference. | |||
| Image Management | |||
| Software | |||
| Specification | Predicate device K192364 | Subject Device | Impact of Differences |
| Horizontal Flip | Available | Available | None |
| Vertical Flip | Available | Available | None |
| Rotate CW/CCW | Available | Available | None |
| Text Annotation | Available | Available | None |
| Ruler: Distance tool | Available | Available | None |
| Angle measurement | |||
| tool | Available | Available | None |
| Zoom | Available | Available | None |
| Magnify | Available | Available | None |
| Image panning | Available | Available | None |
| Auto fitting to window | |||
| size | Available | Available | None |
| Image crop/cut | |||
| function | Available | Available | None |
| Image Copy | Available | Available | None |
| Recover the original | |||
| image | Available | Available | None |
| Window level | |||
| CD Burning | Available | Available | None |
| DICOM Print | Available | Available | None |
| Image Stitching | Available | Available | None |
7
VII. PERFORMANCE DATA
Nonclinical Testing:
Summary:
Based on the performance as documented in the testing, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device.
The complete system has been assessed and tested at the factory and by Standards testing facilities. GXR-Series Diagnostic X-Ray System, has passed all predetermined testing criteria. 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.
The following International Standards were used to develop and verify the system. GXR-Series Diagnostic X-Ray System, device has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):
| Std # | Safety/EMC Standards Description | FDA
Consensus
Standard # |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| IEC 60601-1 | Medical electrical equipment, Part 1: General requirements for
basic safety and essential performance | 19-4 |
| IEC 60601-1-3 | Medical electrical equipment
Part 1-3: General Requirements for Radiation Protection in
Diagnostic X-Ray Equipment | 12-269 |
| IEC 62366 | This part of IEC 62366-1:2015 specifies a process for a
manufacturer to analyze, specify, develop and evaluate the
usability of a medical device as it relates to safety | 5-129 |
8
| Std # | Safety/EMC Standards Description | FDA
Consensus
Standard # |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| IEC 60601-2-28 | IEC 60601-2-28
Medical electrical equipment Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for
medical diagnosis. | 12-204 |
| 60601-2-54 | IEC 60601-2-54 Medical electrical equipment Part 2: Particular
requirements for the basic safety and essential performance of X-
ray equipment for radiography and radioscopy | 12-296 |
| IEC 60601-1-2
(EMC) | IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances
Requirements and tests. | 19-8 |
| IEC 62304 | ANSI AAMI IEC 62304:2015
Medical device software - Software life cycle processes | 13-79 |
| NEMA PS 3.1 | NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications
in Medicine (DICOM) Set DICOM Standard. | 12-300 |
| IEC/ISO10918-1 | JPEG Standard IEC/ISO10918-1 First edition 1994-02-15,
Information technology - Digital compression and coding of
continuous-tone still images: Requirements and guidelines
[Including: Technical Corrigendum 1 | 12-261 |
| IEC 62494-1 | IEC 62494-1 Edition 1.0 (2008-08), Medical electrical equipment -
Exposure index of digital X-ray imaging systems - Part 1:
Definitions and requirements for general radiography. | 12-215 |
| ISO 14971: | ISO 14971:2007/(R)2010 (Corrected 4 October 2007), Medical
devices - Applications of risk management to medical devices. | 5-40 |
| ISO 15223-1 | ISO 15223-1 Third Edition 2016-11-01, Medical devices - Symbols
to be used with medical device labels, labelling, and information to
be supplied - Part 1: General requirements. | 5-117 |
Conclusion:
The 510(k) Pre-Market Notification for the 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 will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate device.