September 19, 2023

DRGEM Corporation
℅ Mr. Park Sunghee
Quality Management Director
7F/13F, E-B/D Gwangmyeong Techno-Park, 60Haan-ro
Gwang-Myeong-si, Gyeong-gi-do 14322
KOREA

Re: K232178
Trade/Device Name: GXR-ES/ECS Diagnostic X-Ray System,
(Models GXR-ES series, GXR-ECS series)
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Code: KPR
Dated: July 24, 2023
Received: July 24, 2023

Dear Mr. Sunghee:

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.30
Silver Spring, MD 20993
www.fda.gov
K232178 - Mr. Park Sunghee Page 2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K232178

Device Name
GXR-ES/ECS Diagnostic X-ray System, (Models : GXR-ES series, GXR-ECS series)

Indications for Use (Describe)

The “GXR-ES/ECS” System is intended for use in generating radiographic images of human anatomy. The Diagnostic X-
ray System consisting of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table,
wall Bucky stand, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for
diagnosis of diseases in skeletal, respiratory and urinary systems. Such as the skull, spinal column, chest, abdomen,
extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or
supine position

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.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 510(k) Summary
K232178

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: sunghee.park@drgem.co.kr
TEL: +82-2-869-8566, FAX: +82-2-869-8567
Contact Person: Mr.Sung-Hee PARK, Director | Quality
Management Date Prepared: May 25, 2023

II. PROPOSED DEVICE INFORMATION [21 CFR 807.92(a) (2)]

Product Name: GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series,
GXR-ECS series)
Common Name: Stationary X-Ray System
Classification Name: Stationary x-ray system
Product Code: KPR
Regulatory Class: II
Regulation Number: 892.1680

III. PREDICATE DEVICES INFORMATION [21 CFR 807.92(a) (3)]

Product Name: GXR-series Diagnostic X-Ray System, (Models GXR-S series)
Common Name: Stationary X-Ray System
Classification Name: Stationary x-ray system

510(k) Number : K202572

Product Code: KPR
Regulatory Class: II
Regulation Number: 892.1680

IV. DEVICE DESCRIPTION [21 CFR 807.92(a) (4)]

Device Features:

The GXR-ES/ECS system offers stable operation and good performance, delivering state-of-the-art
image quality with good quality images.

This diagnostic x-ray system is designed to diagnose human body by providing radiographic x-ray
image with anatomical structure.

The flat-panel detectors (a necessary component of a fully-functional diagnostic x-ray system) are not
part of the subject device.

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 “GXR-ES/ECS” System provides good performance and stable operation while providing good quality
images.

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.

The “GXR-E/EC” Series high frequency X-ray generator features excellent accuracy, reproducibility
and long-term stability with UPS functionality.

The APR (Anatomical Programming) and the optional AEC (Automatic Exposure Control) features
give you controlled exposure factors, automatically optimized for the radiological study selected.
Automatic Calibration function of the generator will minimize calibration time and set correct
calibration value.
Also the control console of “GXR-ES/ECS” System 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.

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 control console allows the operator to select the technique factors, image receptors, etc., and to
initiate an X-ray exposure.
.
• Compact System for essential uses.
• Good Performance and Stability.
• Real-time monitoring self-diagnosis function and Error code display.
• Overload & HU protection and error message display.
• Automatic calibration without measurement equipment.
• Adaptable calibration keeps up accuracy through long-term usage.
• The system is small, light and features a convenient modular design and user-friendly system
configuration.
• Constant dose output due to kV and mA regulation during exposures.
• Large graphic LCD panel user-friendly controls for APR and technique display at a glance.
• Time and mA / mAs selections are based on R’10 rule of ISO 497.
• Remote diagnosis software for system diagnosis via internet.
• Easy parameter setting and Firmware upgrade.
• System diagnosis, Error log and Statistical data display.

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 ∙ Device Identification:

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.

∙ Device Characteristics:

Software

The subject device ‘GXR-ES/ECS Diagnostic X-ray System’ use software (firmware).

Its S/W can perform system control such as the collimation size, filter selection, Control of Generator.

The software being used is identical to the predicate device “GXR-S 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.

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-ES/ECS” 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-ES/ECS” 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,
the film detects X-rays incident through the incident surface during X-ray irradiation, and finally
generates a radiographic image when X-ray irradiation is completed.

∙ Material of Use:

The “GXR-E/EC series Diagnostic X-ray System has a two patient-applied part.

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 Some device components may briefly touch the patient. Device biocompatibility has been tested
according to relevant standards and it was found that critical components satisfy biocompatibility
requirements as applicable to the device Indications for Use.

∙ Compatible x-ray image detector:

This model is an analog-based X-ray system and does not include image detectors as an essential
component. It is possible to compatible with available detectors and can be used with certified
detector panel sizes as long as they fit.

• Available detector
- Size (inch): 17X17, 17X14, 10 X12
- Products whose compatibility has been verified by the manufacturer can be used.

V. INDICATION FOR USE [21 CFR 807.92(a) (5)]

“GXR-ES/ECS” System is indicated for use in generating radiographic images of human anatomy.
The Diagnostic X-ray System consisting of a high voltage (HV) generator, a tube support unit, an X-
ray beam limiting device, patient table, wall Bucky stand, and a tube, operates on a high-frequency
inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory
and urinary systems. Such as the skull, spinal column, chest, abdomen, extremities, and other body
parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine
position

VI. TECHNOLOGICAL CHARACTERISTICS [21 CFR 807.92(a) (6)]

The subject device and the primary predicate device are stationary x-ray devices. There
will be 2 main differences:

First, this device, 'GXR-ES/ECS Diagnostic X-ray System has Compact System', is for
only essential use in that it is composed of simplified mechanical parts.
But, the predicate device ‘GXR- series Diagnostic Imaging System’ has Manual type as
well as motorized option of Tube stand, patient table and WBS (Diagnostic X-ray Full
system). And the subject device has lower high voltage output rating than predicate
device for Use of small-scale hospital facility operation.

Second, Difference between subject and predicate device is diversity of the power
supply method of the generator
Generally, the subject device ‘GXR-ES, ECS’ has general and capacitor type generator
supplied from wall power. However, the predicate device ‘GXR-series Diagnostic
Imaging System’ has also UPS battery type (total three type).

Differences between the subject device and the predicates has no impact on safety or
effectiveness 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.

Page 4 / 9
 VII.SUBSTANTIAL EQUIVALENCE [21 CFR 807.92(b)]

Item Subject Device Predicate Device Impact of Differences

GXR-Series
GXR-ES/ECS Series Diagnostic Diagnostic X-Ray
Device Name Not applicable
X-ray System System (K202572)

DRGEM Corporation DRGEM Corporation

Manufacturer Not applicable

GXR-ES series,
GXR-S series
Model Number GXR-ECS series Not applicable

High Frequency X- ray Generator

Yes, there is a difference in output

32KW, 40KW,
values but no difference in
Output Power 20kW, 25kW, 32kW, 40kW, 52KW, 68KW,
generators.
50kW 82KW
See Difference Explanation below.

Yes, there is a difference.

Models have been tested against
International Safety and EMC
Standards. Any differences
between the subject device and
Generator GXR-32, GXR- 40, GXR- predicate device do not change or
models GXR-E20, GXR-E25, 52, GXR-68, GXR- 82 add new potential safety risks. It is
(manufactured GXR-E32, GXR-E40, our determination that there is “No
by DRGEM) GXR-E50 negative impact on safety or
effectiveness” and there are no new
potential
or increased safety risks concerning
this difference.

Yes, there are differences in line

voltage depending upon the system
requirements. Models have been
tested against International Safety
and EMC Standards. Any
differences between the subject
device and predicate device do not
100~120VAC 220~230VAC, change or add new potential safety
Line voltage 200~240VAC 380/400/480VA C, risks. It is our determination that
there is “No negative impact on
safety or efficacy” and there are no
new potential or increased safety
risks
concerning this difference

Image Acquisition System

Page 5 / 9
 Not applicable

Flat panel Detector is not supplied

Detector is not supplied with
Detector with system
system

Patient table
Yes, there is a difference.
Models have been tested against
International Safety and EMC
Configuration PBT-E PBT-4, PBT-6, PDT-1 Standards. Any differences
model between the subject device and
predicate device do not change or
add new potential safety risks. It is
Longitudinal : Longitudinal : our determination that there is “No
Movement 1050mm ± 10mm 1000mm ± 500mm negative impact on safety or
effectiveness” and there are no new
potential
or increased safety risks concerning
this difference
Wall Bucky stand

Configuration WBS-E, WBS WBS, WBS-TM Yes, there is a difference.

model Models have been tested against
International Safety and EMC
Standards. Any differences
between the subject device and
Dimension/weight 560(W) x 690(D) x 1,826(H)mm / 659(W) x 445(D) x predicate device do not change or
32.4kg(71.4lbs) (Floor Base) 1,599(H)mm / 110kg(242lbs) add new potential safety risks. It is
our determination that there is “No
420(W) x 256(D) x 1,826(H)mm / 659(W) x 445(D) x negative impact on safety or
21.4kg(47.2lbs) (Floor-Wall 1,749(H)mm / 113kg(249lbs) effectiveness” and there are no new
Mounted) potential
659(W) x 445(D) x or increased safety risks concerning
659(W) x 393(D) x 2,169(H)mm / 1,919(H)mm / 116kg(255lbs) this difference
120kg(264lbs)
659(W) x 445(D) x
2,169(H)mm / 120kg(264lbs)

Tube stand
Not applicable

TS-FC6, TS-FC4, TS-

Configuration TS-FT6, TS-FT4 FC2
model TS-FM6, TS-CSA, TS-
CSE

Tube Rotation ±135° ±135°

Angle
X-ray tube

Page 6 / 9
 No Impact of difference
E7239X, DXT-8M,
E7242X, DXT-11M
E7843X, DXT-10M
Configuration DXR-8M, DXT-10M, DXT- E7876X, DXT-12M
model 11M, DXR-12M, E7239X, E7884X, E7252X
E7242X, E7884X, DXT-14U, RAD-14U,
DXT-15U, RAD-21
RAD-60, E7255FX,
E4254FX

Max. kV 125kV, 150kV 125kV, 150kV

Collimator
Yes, there is a difference.
Models have been tested against
International Safety and EMC
DXC-RML, DXC-RMH Standards. Any differences
Configuration MCR, R108, R302A, between the subject device and
model DXC-RML R302MLP/A, predicate device do not change or
R302MFMLP/A 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
Lamp Type LED lamp LED and Halogen lamp this difference
(Over 160LUX at 100cm (Over 160LUX at 100cm
SID) SID)

Page 7 / 9
 VIII. SUMMARY OF NON-CLINICAL Data [21 CFR 807.92(b) (1)]
Nonclinical Testing:
The GXR-ES/ ECS 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.

FDA Rec.
Std # Safety/EMC Standards Description
Standard #
Medical electrical equipment
IEC 60601-1-3
Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray 12-269
Equipment
IEC 60601-1-6 IEC 60601-1-6 Edition 3.1 2013-10 5-89
Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability
IEC 60601-2-28
IEC 60601-2-
Medical electrical equipment Part 2: Particular requirements for the safety of X-ray 12-309
28
source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-54
IEC 60601-2- Medical electrical equipment
12-317
54 Part 2: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - Part 1-2: General
IEC 60601-1-2
requirements for basic safety and essential performance - Collateral Standard: 19-8
(EMC)
Electromagnetic disturbances Requirements and tests.
IEC IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
13-79
62304:2006 Medical device software - Software life cycle processes
Medical electrical equipment, Part 1: General requirements for basic safety and
IEC 60601-1 19-4
essential performance

ISO ISO 14971:2019 Third Edition, Medical devices - Applications of risk management to
5-125
14971:2019 medical devices.

ISO 15223-1 Fourth Edition 2021-07, Medical devices - Symbols to be used with
ISO 15223-1 medical device labels, labelling, and information to be supplied - Part 1: General 5-134
requirements.
TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and
TR 60601-4-2 interpretation - Electromagnetic immunity: performance of medical electrical equipment 19-19
and medical electrical systems

FDA Guidance Pediatric Information for X-ray Imaging Device Premarket Notifications dated November 28, 2017

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance

FDA Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014

Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software
FDA Guidance
contained in Medical Devices, Document issued on: May 11, 2005 Medical Devices, Document issued
on: May 11, 2005

Page 8 / 9
 Summary:
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 above standards were used to develop and verify electrical safety, and EMC. GXR-
ES/ ECS Series Diagnostic X-Ray System device has met all the requirements listed in
the Standards except for inapplicable requirements.
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-ES/ECS 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.

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