(45 days)
No
The document describes automated functions based on pre-programmed settings and anatomical study selection, but does not mention AI, ML, or any related concepts like deep learning or neural networks. The image processing mentioned is likely standard digital image processing, not AI/ML-based analysis.
No.
The device is a diagnostic x-ray system used to generate images, not to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "stationary digital diagnostic x-ray system."
No
The device description clearly outlines multiple hardware components including an x-ray system, digital flat panel detector, motorized U-arm, mobile patient table, x-ray source components (tube assembly, collimator, HV cable, generator), and a touch screen LCD console. While it includes imaging software, it is an integral 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 "generating radiographic images of human anatomy." This is a diagnostic imaging device that works by producing images of the internal structure of the body using X-rays.
- Device Description: The description details components like an X-ray tube, generator, detector, and control console, all of which are characteristic of an X-ray imaging system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological or pathological state. The provided text does not mention any interaction with biological specimens or analysis of such specimens.
Therefore, the DIAMOND-5A/6A/8A is a radiographic imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammography, bone density, fluoroscopy and angiography applications.
Product codes
KPR
Device Description
DIAMOND-5A/6A/8A, system is a digital radiographic system. There are 3 power output configurations which are reflected in the model designation "5A/6A/8A". The models have 3 different output power ratings:
| System Model | DIAMOND-5A | DIAMOND-6A | DIAMOND-8A |
|---|---|---|---|
| X-Ray Generator | GXR-52 | GXR-68 | GXR-82 |
| Output Rating | 52kW | 68kW | 82kW |
DIAMOND 5A/6A/8A, incorporates digital flat panel detector technology, along with an automatic motorized U-arm radiographic stand and mobile patient table that can fit into smaller rooms without the need of ceiling support structures for X-Ray tube suspensions. The subject device comes in 2 hardware configurations; a Radiographic Stand configuration for a wired detector and a Radiographic Stand for removable detectors. The main components of the subject device are the same as the predicate. Components of the x-ray source are the tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD based x-ray control console provides a user interface and technique selection. The automatic collimator supports high accuracy for selected x-ray field size over SID.
Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study. Also, removable high-resolution grids which have 100 and 180cm (40 and 72 inch) focal distance. The integrated touch screen console located on the tube side, operator can easily control the radiographic techniques and stand positioning. Furthermore, the operator can verify the digital x-ray image on this screen. The GUI, automatically rotates corresponds to rotation angle of U-arm.
The Radiographic stand has four motorized joints, and automatic positioning can be accomplished by preprogrammed data which can be easily reprogrammed by operator. Total of seven safety sensors are located over U-arm, detector and tube side to protect against collision with patient or obstacles to control the speed or stop the positioning. Also, a mobile patient table with heavy patient load is provided for radiographic study which needs table. A remote-control is provided for remote motorized control of the stand, and the movement will stop as soon as the key is no longer pressed.
The subject device contains the same image handling software as the predicate device called RADMAX. RADMAX Digital Imaging Software, was cleared under K182537 and used in the predicate. RADMAX can perform image management and system control such as the collimation size, filter selection, etc. for the GXR series xray generators.
The digital flat panel digital detectors that are used in the subject device are:
- Fujifilm, DR-ID 1272SE/ DR-ID 1274SE cleared under K142003.
- Varex, PaxScan4343W cleared under K161459, and
- i-Ray, Mano4343W cleared under K201043.
- In addition to VAREX Model 4343Rv3 (Ethernet interface) and 4336Wv4 (wireless), used in the predicate.
Mentions image processing
Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study.
Selection of an anatomical study on the imaging software, (RADMAX), automatically sets up the x-ray generator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human 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:
The complete system has been assessed and tested at the factory and by Standards testing facilities. DIAMOND-5A/6A/8A, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DIAMOND-5A/6A/8A (K192453)
Reference Device(s)
K182537, K142003, K161459, K201043
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 10, 2020
Image /page/0/Picture/1 description: The image contains 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 Regulatory Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K202156
Trade/Device Name: DIAMOND-5A/6A/8A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: August 15, 2020 Received: August 19, 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) K202156
Device Name DIAMOND-5A/6A/8A
Indications for Use (Describe)
DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammography, bone density, fluoroscopy and angiography 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) |
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3
Submission number: K202156
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: August 11, 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: DIAMOND-5A/6A/8A 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
The DIAMOND-5A/6A/8A subject device is substantially equivalent to: DIAMOND-5A/6A/8A (K192453), by DRGEM, product code KPR. Requlation 21 CFR 892.1680
IV. DEVICE DESCRIPTION
DIAMOND-5A/6A/8A, system is a digital radiographic system. There are 3 power output configurations which are reflected in the model designation "5A/6A/8A". The models have 3 different output power ratings:
| System Model | DIAMOND-5A | DIAMOND-6A | DIAMOND-8A |
|---|---|---|---|
| X-Ray Generator | GXR-52 | GXR-68 | GXR-82 |
| Output Rating | 52kW | 68kW | 82kW |
DIAMOND 5A/6A/8A, incorporates digital flat panel detector technology, along with an automatic motorized U-arm radiographic stand and mobile patient table that can fit into smaller rooms without the need of ceiling support structures for X-Ray tube suspensions. The subject device comes in 2 hardware configurations; a Radiographic Stand configuration for a wired detector and a Radiographic Stand for removable detectors. The main components of the subject device are the same as the predicate. Components of the x-ray source are the tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD based x-ray control console provides a user interface and technique selection. The automatic collimator supports high accuracy for selected x-ray field size over SID.
Selection of an anatomical study on the imaqing software automatically sets up the x-ray generator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study. Also, removable high-resolution grids which have 100 and 180cm (40 and 72 inch) focal distance. The integrated touch screen console located on the tube side, operator can easily control the radiographic techniques and stand positioning. Furthermore, the operator can verify the digital x-ray image on this screen. The GUI, automatically rotates corresponds to rotation angle of U-arm.
4
Submission number: K202156
- . Selection of an anatomical study on the imaging software, (RADMAX), automatically sets up the x-ray qenerator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study. Also, removable high-resolution grids which have 100 and 180cm (40 and 72 inch) focal distance supplies excellent image quality per each SID. The integrated touch screen console located in the tube side, operator can easily control the radiographic techniques and stand positioning. Furthermore, the operator can verify the digital x-ray image on this screen. The GUI, automatically rotates corresponds to rotation angle of U-arm.
- . The Radiographic stand has four motorized joints, and automatic positioning can be accomplished by preprogrammed data which can be easily reprogrammed by operator. Total of seven safety sensors are located over U-arm, detector and tube side to protect against collision with patient or obstacles to control the speed or stop the positioning. Also, a mobile patient table with heavy patient load is provided for radiographic study which needs table. A remote-control is provided for remote motorized control of the stand, and the movement will stop as soon as the key is no longer pressed.
- The subject device contains the same image handling software as the predicate . device called RADMAX. RADMAX Digital Imaging Software, was cleared under K182537 and used in the predicate. RADMAX can perform image management and system control such as the collimation size, filter selection, etc. for the GXR series xray generators.
DIAMOND 5A/6A/8A, incorporates digital flat panel detector technology, along with an automatic motorized U-arm radiographic stand and mobile patient table that can fit into smaller rooms without the need of ceiling support structures for X-Ray tube suspensions.
The digital flat panel digital detectors that are used in the subject device are:
- Fujifilm, DR-ID 1272SE/ DR-ID 1274SE cleared under K142003 .
- . Varex, PaxScan4343W cleared under K161459, and
- . i-Ray, Mano4343W cleared under K201043.
- . In addition to VAREX Model 4343Rv3 (Ethernet interface) and 4336Wv4 (wireless), used in the predicate.
V. INDICATIONS FOR USE
DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammography, bone density, fluoroscopy and angiography applications.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Summary of differences:
The subject device can use three previously cleared digital flat panel detectors in addition to the detectors used in the predicate device. The added detectors are:
- Fujifilm, DR-ID 1272SE/ DR-ID 1274SE cleared under K142003
- . Varex, PaxScan4343W cleared under K161459
- i-Ray, Mano4343W cleared under K201043 .
The following information compares the subject device to the predicate and subject device.
Any differences between the subject device and the predicated device has 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.
5
Submission number: K202156
| Specification | Predicate Device -
K192453 | Subject Device | Impact of Differences |
|--------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIAMOND 5A/6A/8A | DIAMOND 5A/6A/8A | No difference |
| Manufacturer | DRGEM Corporation | DRGEM Corporation | No difference |
| Model Number | DIAMOND 5A/6A/8A | DIAMOND 5A/6A/8A | No difference |
| High Frequency X-
ray Generator | | | |
| Output Power | 52KW, 68KW, 82KW | 52KW, 68KW, 82KW | No difference |
| Generator models
(manufactured by
DRGEM) | GXR-52, GXR-68,
GXR-82 | GXR-52, GXR-C52,
GXR-68, GXR-82 | GXR-C52 X-Ray Generator is
added and uses single phase
220/230V whereas the other
generator models use 3 phase
380/400/480V |
| Image Acquisition | | | |
| Detectors | VAREX, Model
4343Rv3 | VAREX, Model 4343Rv3
Fujifilm, Models DR-ID 1272SE/DR-ID 1274SE
Varex, Model PaxScan4343W
i-Ray, Model Mano4343W | Differences: 3 additional flat
panel detectors:
Fujifilm; K142003
Varex; K161459
iRAY; K201043
The system has been tested
and there is no negative impact
on safety or efficacy and there
are no new potential or
increased safety risks
concerning these differences. |
| Image Management
Software & System
control | RADMAX Digital
Imaging Software -
K182537 | RADMAX Digital
Imaging Software -
K182537 | No significant differences.
RADMAX in the subject device
is the latest Image
Management software, version
1.01. The system has been
tested and there is no negative
impact on safety or efficacy and
there are no new potential or
increased safety risks
concerning this difference. |
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. DIAMOND-5A/6A/8A, 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
6
Submission number: K202156
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. DIAMOND-5A/6A/8A, device has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):
The main components of DIAMOND-5A/6A/8A comply with the regulatory requirements and design standards in this section as follows:
| Std # | Safety/EMC Standards Description | FDA Rec.
Standard # |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| IEC 60601-1-3 | Medical electrical equipment
Part 1-3: General Requirements for Radiation Protection in
Diagnostic X-Ray Equipment | 12-269 |
| IEC 62366 (IEC
60601-1-6) | IEC 62366:2007 + A1:2014 – Usability engineering process
checklist | 5-114 |
| 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 |
| IEC 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 62304:2006 | ANSI AAMI IEC 62304:2006
Medical device software - Software life cycle processes | 13-79 |
| IEC 60601-1 | Medical electrical equipment, Part 1: General requirements
for basic safety and essential performance | 19-4 |
| 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 14971:2007 | 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 |
| Std # | Safety/EMC Standards Description | FDA Rec.
Standard # |
| IEC 62366-
1:2015 | This part of IEC 6 2366 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 |
7
Submission number: K202156
Conclusion:
The 510(k) Pre-Market Notification for the DIAMOND-5A/6A/8A, 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.