The GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S), 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.

Device Description

The GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S) is comprised of 2 main configurations: GXR-SD and GXR-S, with SGXR-S, FDR Smart FGXR-S being different brand names for GXR-S. Both configurations are designed to diagnose the human body by providing radiographic x-ray image with anatomical structure.

GXR-S, SGXR-S, FDR Smart FGXR-S (analog) and GXR-SD (digital) have the same xray hardware components. However, the GXR-SD model contains image management (PACS) software and a flat panel digital detector. Interoperability is defined in the DICOM Conformance Statement which is part of the device labeling and is based upon NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard.

The GXR-S does not have image management software and does not have a digital detector.

The GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S, models consist of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, 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 simple and 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 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.

RADMAX Digital Imaging Software (K182537) by DRGEM, is used in the GXR-SD model to serve as an interface to the hardware and images. Anatomical view-based digital image processing automatically optimizes and enhances the quality of the captured images.

AI/ML Overview

The provided document, a 510(k) Premarket Notification summary for the GXR-Series Diagnostic X-Ray System, does not contain the detailed information typically presented in a study proving a device meets acceptance criteria for an AI/CADe (Computer-Aided Detection/Diagnosis) system.

This document describes a traditional X-ray system, not an AI software. The performance data highlighted is primarily related to non-clinical testing, electrical safety, EMC (Electromagnetic Compatibility), and conformance to various medical device standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1 DICOM). These are standard requirements for X-ray hardware, not for AI software performance in diagnostic tasks.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/CADe system from this document. The sections you asked for, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, would be found in a submission for an AI-powered diagnostic device, which this is not.

The "Performance Data" section in the document specifically mentions "Nonclinical Testing" and lists several international standards for electrical safety and electromagnetic compatibility (EMC), as well as software lifecycle processes (IEC 62304) and risk management (ISO 14971). It concludes that "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." However, it does not specify what those acceptance criteria for clinical performance are, as it is a hardware device.

If you have a document describing an AI/CADe device, please provide that, and I will be able to answer your questions.

Summary

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September 26, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" in a larger font size and a blue square behind it.

DRGEM Corporation % Mr. Carl Aletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K192364

Trade/Device Name: GXR-Series Diagnostic X-Ray System (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: August 27, 2019 Received: August 30, 2019

Dear Mr. Aletto:

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

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801; medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K192364

Device Name

GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S)

Indications for Use (Describe)

The GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, FDR Smart FGXR-S), 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)

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Image /page/3/Picture/1 description: The image shows the logo for DRGEM, a healthcare provider. The logo consists of 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, italicized font. The alphanumeric code "K192364" is printed below the tagline.

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

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 TEL: +82-2-869-8566, FAX: +82-2-869-8567

Contact Person: Mr. Ki-Nam YANG, Director | QM representative

Date Prepared: September 25, 2019

Regulatory Consultant:

Carl Alletto, OTech Inc. 215 E University Dr., Suite B Denton, TX 76209-2011, USA Email: carl@otechimq.com TEL: (940) 440-9791

II. DEVICE

Product Name:	GXR-Series Diagnostic X-Ray System, (Models GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S)
Common Name:	Stationary X-Ray System
Classification:	Stationary x-ray system, 21 CFR 892.1680
Product Code:	KPR, MQB
Regulatory Class:	II

III. PREDICATE DEVICES

Primary Predicate Device DIAMOND K102408, by DRGEM, product code KPR.

Reference Predicate Device

RADMAX Digital Imaging Software, K182537, by DRGEM, product code: LLZ

IV. DEVICE DESCRIPTION

The GXR-S does not have image management software and does not have a digital detector.

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Image /page/4/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The logo consists of the text "DRGEM" in a bold, sans-serif font. The "DR" is in black, while the "GEM" is in teal. Below the company name is the text "Your Best Healthcare" in a smaller, sans-serif font, also in teal. The logo is simple and modern, and the colors are professional and trustworthy.

Note 1: RADMAX (K182537) Digital Imaging Software (the Reference Predicate) is a digital X-ray image processing software designed for acquiring images and processing 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, filter selection, etc. for the GXR-S series."

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject device and the primary predicate device are stationary x-ray devices. There will be 2 main configurations: GXR-SD that includes a flat panel detector, and the models GXR-S, SGXR-S, FDR Smart FGXR-S do not have a detector. The GXR-Series Diagnostic X-Ray System, GXR-SD Models will use the integrated reference predicate (RADMAX K182537) device PACS image management processing software. The GXR-S, SGXR-S, FDR Smart FGXR-S models will not have image management processing software and images must be processed with other PACS workstation software.

Any differences between the subject device and the predicates and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.

Item	Subject Device	Predicate Device	Reference Predicate	Impact of Differences
Device Name	GXR-Series Diagnostic ImagingSystem	DIGITALDIAGNOSTIC X-RAY SYSTEM(K102408)	RADMAX DigitalImaging SystemSoftware (K182537)	Not applicable
Manufacturer	DRGEMCorporation	DRGEMCorporation	DRGEM Corporation	Not applicable

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Image /page/5/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 is the text 'Your Best Healthcare' in a smaller, lighter font.

Model Number	GXR-S, SGXR-S, FDR SmartFGXR-S	GXR-SD	DIAMOND5A/6A/8A	RADMAX	Not applicable
HighFrequency X-ray Generator
Output Power	32KW, 40KW,52KW, 68KW,82KW	32KW, 40KW,52KW, 68KW,82KW	52KW, 68KW,82KW	Not applicable,RADMAX is imagemanagementsoftware and doesnot have OutputPower.	Yes, there is a difference inoutput values but nodifference in generators.See Difference Explanationbelow.
Generatormodels(manufacturedby DRGEM)	GXR-32, GXR-40, GXR-52,GXR-68, GXR-82	GXR-32, GXR-40, GXR-52,GXR-68, GXR-82	GXR-52, GXR-68,GXR-82	Not applicable	Yes, there is a difference.Models have been testedagainst International Safetyand EMC Standards. Anydifferences between thesubject device andpredicate device do notchange or add newpotential safety risks. It isour determination that thereis "No negative impact onsafety or efficacy" andthere are no new potentialor increased safety risksconcerning this difference.
Line voltage	220~230VAC,380/400/480VAC,	220~230VAC380/400/480VAC	400/480VAC	Not applicable	Yes, there are differencesin line voltage dependingupon the systemrequirements. Models havebeen tested againstInternational Safety andEMC Standards. Anydifferences between thesubject device andpredicate device do notchange or add newpotential safety risks. It isour determination that thereis "No negative impact onsafety or efficacy" andthere are no new potentialor increased safety risksconcerning this difference
ImageAcquisition
Detector	Detector notsupplied withsystem	VAREXModel 4343Rv3Model 4336Wv4	VAREXModel 4343R v3Model 4336W v4	Not applicable	Yes, there is a difference.The model GXR-Spredicate device does nothave the detector as part ofthe system but is suppliedby the User. The systemhas been tested and thereis "No negative impact onsafety or efficacy" andthere are no new potentialor increased safety risksconcerning this difference.
ImageManagement
Software
Horizontal Flip	Not available	Available	Available	Available	Yes, there is a difference.The GXR-S models, doesnot have image processingsoftware since there is noflat panel delivered as partof the system. The usermust process images usingother PACS workstations.The system has beentested and there is "Nonegative impact on safetyor efficacy" and there areno new potential orincreased safety risksconcerning this difference.
Vertical Flip	Not available	Available	Available	Available	Same as above
RotateCW/CCW	Not available	Available	Available	Available	Same as above
TextAnnotation	Not available	Available	Available	Available	Same as above
Ruler: Distancetool	Not available	Available	Available	Available	Same as above
Anglemeasurementtool	Not available	Available	Available	Available	Same as above
Zoom	Not available	Available	Available	Available	Same as above
Magnify	Not available	Available	Available	Available	Same as above
Image panning	Not available	Available	Available	Available	Same as above
Auto fitting towindow size	Not available	Available	Available	Available	Same as above
Image crop/cutfunction	Not available	Available	Available	Available	Same as above
Image Copy	Not available	Available	Available	Available	Same as above
Recover theoriginal image	Not available	Available	Available	Available	Same as above
Window levelCD Burning	Not available	Available	Available	Available	Same as above
DICOM Print	Not available	Available	Available	Available	Same as above
ImageStitching	Not available	Available	Available	Available	Same as above

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Image /page/6/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The logo consists of the text "DRGEM" in two different colors. The "DR" is in black, while the "GEM" is in teal. Below the company name is the text "Your Best Healthcare" in a smaller font size and a lighter color.

VII. PERFORMANCE DATA

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.

Summary:

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Image /page/7/Picture/0 description: The image shows the logo for DRGEM. The letters "DR" are in bold black font, while the letters "GEM" are in a teal color. Below the letters, the words "Your Best Healthcare" are written in a smaller, lighter font.

Based on the performance as documented in the V&V Testing, 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 device 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 1020.30-31.

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-RayEquipment	12-269
IEC 62366	IEC 62366:2007 + A1:2014 - Usability engineering process checklist	5-114
IEC 60601-2-28	IEC 60601-2-28Medical electrical equipment Part 2: Particular requirements for the safety of X-raysource assemblies and X-ray tube assemblies for medical diagnosis	12-204
IEC 60601-2-54	IEC 60601-2-54Medical electrical equipmentPart 2: Particular requirements for the basic safety and essentialperformance 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: Generalrequirements for basic safety and essential performance - Collateral Standard:Electromagnetic disturbances Requirements and tests.	19-8
IEC62304:2006	ANSI AAMI IEC 62304:2006Medical device software - Software life cycle processes	13-32
IEC 60601-1	Medical electrical equipment, Part 1: General requirements for basic safety andessential 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 andguidelines [Including: Technical Corrigendum 1	12-261
IEC 62494-1	IEC 62494-1 Edition 1.0 (2008-08), Medical electrical equipment - Exposure index ofdigital X-ray imaging systems - Part 1: Definitions and requirements for generalradiography.	12-215
ISO14971:2007	ISO 14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices - Applicationsof risk management to medical devices.	5-40
ISO 15223-1	ISO 15223-1 Third Edition 2016-11-01, Medical devices - Symbols to be used withmedical device labels, labelling, and information to be supplied - Part 1: Generalrequirements.	5-117
FDA Guidance	Pediatric Information for X-ray Imaging Device Premarket Notifications datedNovember 28, 2017	Notapplicable
FDA Guidance	Content of Premarket Submissions for Management of Cybersecurity in MedicalDevices Guidance for Industry and Food and Drug Administration Staff DocumentIssued on: October 2, 2014	Notapplicable
Std #	Safety/EMC Standards Description	FDA Rec.Standard #
FDA Guidance	Guidance for Industry and FDA Staff Guidance for the Content of PremarketSubmissions for Software contained in Medical Devices, Document issued on: May11, 2005 Medical Devices, Document issued on: May 11, 2005	Notapplicable
FDA Guidance	Guidance for Industry and FDA Staff Guidance for the Content of PremarketSubmissions for Software contained in Medical Devices, Document issued on: May 11,2005 Medical Devices, Document issued on: May 11, 2005	Notapplicable

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Image /page/8/Picture/0 description: The image contains the logo for DRGEM, a healthcare provider. 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, lighter font.

VIII. CONCLUSIONS

The 510(k) Pre-Market Notification for IntelePACS, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The new device and the primary 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.

Regulation Number and Section

§ 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.