Predicate Devices

Reference Devices

K221345, K210316, K223930, K202572, K210314, K223930

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard mobile X-ray system with digital imaging capabilities. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique" describes a rule-based automation, not AI/ML.

Therapeutic

No.
The 'TOPAZ Mobile X-ray System' is described as obtaining human anatomical images for medical diagnosis, which is an imaging and diagnostic function, not a therapeutic one.

Diagnostic

Yes
The intended use states that the device is for "obtaining human anatomical images of patients...for medical diagnosis." Diagnosis is a key function of diagnostic devices.

SaMD (Software as a Medical Device)

No

The device description explicitly lists numerous hardware components including a motor drive mechanism, column, x-ray source, tube assembly, collimator, HV cable assembly, High Voltage X-Ray Generator, touch screen LCD, flat panel detector, and mechanical parts for mobility. While it includes digital imaging software, it is clearly a system with significant hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The "TOPAZ Mobile X-ray System" is an imaging device that uses X-rays to create images of the inside of the human body. It does not analyze biological specimens.
Intended Use: The intended use clearly states it's for "obtaining human anatomical images... for medical diagnosis." This is consistent with an imaging device, not an IVD.

Therefore, based on the provided information, the "TOPAZ Mobile X-ray System" is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

Product codes

IZL, MQB

Device Description

"TOPAZ" system is a system providing state-of-the-art image quality, user interface. "TOPAZ" system may be moved quietly and smoothly with motor drive mechanism "TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view. The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique. The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from. The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility. The subject device 'TOPAZ Mobile X-ray System' use software (including firmware). Its S/W (RADMAX) can perform processing the radiological image acquired from Solid State X-ray Imaging Device.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Human anatomical images

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professional Facility

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 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.
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. 'TOPAZ Mobile X-ray System' has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports).
The subject device conforms to all applicable requirements of 21 CFR 1020.30-31

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201124

Reference Device(s)

K221345, K210316, K223930, K202572, K210314, K223930

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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December 16, 2024

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

DRGEM Corporation % Arim Kim Regulatory Affairs | Engineer 7F, E-B/D Gwangmyeong Techno-Park 60, Haan-ro GwangMyeong-si, Gyeonggi 14322 SOUTH KOREA

Re: K242015

Trade/Device Name: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 10, 2024 Received: December 3, 2024

Dear Arim Kim:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

2

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242015

Device Name

TOPAZ Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D)

Indications for Use (Describe)

The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

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/4/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.

510(k) Summary

K242015

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, KR 14322 Email: arkim@drgem.co.kr TEL: +82-70-4901-2743, FAX: +82-2-869-8567 Contact Person: Ms. Arim KIM, Engineer | Regulatory Affairs Date Prepared: June 15, 2024

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

Product Name:	TOPAZ Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D)
Common Name:	Mobile x-ray system
Classification Name:	Mobile x-ray system
Product Code:	IZL
Regulation Number:	892.1720
Associated Product Code:	MQB
Regulatory Class:	II

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

Product Name: TOPAZ Mobile DR System (Models: TOPAZ-32D, TOPAZ-40D) Common Name: Mobile x-ray system Classification Name: Mobile x-ray system

510(k) Number: K201124 Product Code: IZL Requlation Number: 892.1720

Regulatory Class: ==============================================================================================================================================================================

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

● Device Features:

· TOPAZ Mobile X-ray System

"TOPAZ" system is a system providing state-of-the-art image quality, user interface.

"TOPAZ" system may be moved quietly and smoothly with motor drive mechanism

"TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view.

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Image /page/5/Picture/0 description: The image contains the logo for DRGEM. The logo has the text "DRGEM" in bold, with "DR" in black and "GEM" in teal. Below the logo is the text "Your Best Healthcare" in a smaller, lighter font.

The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID.

Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch.

Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique.

The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from.

● Device Identification:

The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility.

● Device Characteristics:

·Software

The subject device 'TOPAZ Mobile X-ray System' use software (including firmware).

Its S/W (RADMAX) can perform processing the radiological image acquired from Solid State X-ray Imaging Device.

Software being used is identical to the predicate device 'TOPAZ Mobile X-ray System', and its LOC (Level of Concern) is ' Basic Documentation Level'.

Accordingly, this software (RADMAX) is based on predicate device 'TOPAZ Mobile X-ray System'.

·Software Level Determination

Basic Documentation Level

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.

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Image /page/6/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the company name is the tagline "Your Best Healthcare" in a smaller, lighter font.

·Cybersecurity

This device complies with cybersecurity requirements by ensuring the confidentiality, integrity, and availability of data and systems.

Potential vulnerabilities were identified through cybersecurity risk analysis, which included threat modeling, risk assessment, and the development of a software bill of materials. The design integrates security controls, such as authentication, encryption, integrity verification, event detection and logging, retention, recovery and secure software updates. Verification and tests were conducted to ensure the effectiveness of the implemented cybersecurity controls. The product labeling includes cybersecurity-related information, and users are provided with quidance and training on instruction for use.

● Environment of Use:

This 'TOPAZ Mobile X-ray System' is for use by medical professional Facility. To prevent excess radiation exposure to patient and operator from either primary or secondary radiation, this 'TOPAZ Mobile X-ray System' must be operated and serviced by trained personnel who are familiar with the safety precautions required.

● Brief Written Description of the Device:

The operating principles are as follows.

The irradiation conditions are 40 to 125 (150) kVp at the photographing site, and the tube current is 10 to 400 (500) mA. When X-rays generated under X-ray irradiation conditions enter the X-ray Film or Flat Panel detector, the film or flat panel detects X-rays incident through the incident surface during X-ray irradiation, and finally generates a radiographic image when X-ray irradiation is completed.

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

The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

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

The Subject device 'TOPAZ Mobile X-ray System' (Model: TOPAZ-32D, TOPAZ-40D) is based on the Predicate Device (TOPAZ Mobile DR System, K201124) including the system control, Indication for use and mechanical design.

The differences between the subject device and the predicate device have been thoroughly tested and verified for safety and effectiveness by an accredited Safety and EMC testing laboratory.

This 510(k) submission describes some modifications to the previously cleared predicate devices the 'TOPAZ Mobile DR System' (K201124). The changes to the predicate 'TOPAZ Mobile DR System' (K201124) include:

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Image /page/7/Picture/0 description: The image contains the logo for DRGEM. The letters "DRG" are in black, and the letters "EM" are in teal. Below the logo is the text "Your Best Healthcare" in a smaller font.

Software update from TPZ IWS 1.00.01 to RADMAX 1.02.09

1. Imaging Software Model Name Change: We have changed the model name of our imaging software from 'TPZ IWS (XGRADMAX)' to 'RADMAX'.
Graphical user interface (GUI): GUI of system software updated in order to improve 2) the look and feel of user interface for better visibility & faster workflow.
Image Processing Module added (Module 3, 4): We conducted performance 3) verification of Flat Panel detectors compared to existing image processing modules. Verification and Validation testing concluded no impact on safety and effectiveness.

Component Change

1. 21.5" capacitive touch monitor is applied : 21.5" monitor is applied for improved viewing angle and wide screen.
1. New Collapsible Column Stand Option have been Added (Basic type, Collapsible type - Optional)

: We have added a new Collapsible column type stand option to our product. This collapsible type column stand features a trendy design that allows driving without disturbing the front view.

1. Addition of detector : 4343W, Mars1417X, Mars1717X, Luna1012X, A1417MCW, A1717MCW, F1417MCW

·10x12 inch Wireless Flat Panel detectors have been added

·Luna1012X manufactured by IRAY Technology, FDA Cleared K221345

·14x17 inch Wireless Flat Panel detectors have been added

·Mars1417X manufactured by IRAY Technology, FDA Cleared K210316

·A1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930

·F1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930

·17x17 inch Wireless Flat Panel detectors have been added

·4343W manufactured by Varex Imaging Corp, FDA Cleared K202572

·Mars1717X manufactured by IRAY Technology, FDA Cleared K210314

·A1717MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930

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Image /page/8/Picture/0 description: The image shows the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the company name is the text "Your Best Healthcare" in a smaller font size.

VII.SUBSTANTIAL EQUIVALENCE [21 CFR 807.92(b)]

Substantial Equivalence Comparison Table

Item	Subject Device	Predicate Device	Impact of Differences
Device Name	TOPAZ Mobile X-ray System	TOPAZ Mobile DR System	The TOPAZ Mobile DR System
has been renamed to the
TOPAZ Mobile X-ray System.
This is a simple model name
change, and the differences
between the subject device and
the predicate device do not
affect the safety or efficacy of
the modified device.
510(k) number	K242015	K202572	-
Manufacturer	DRGEM Corporation	DRGEM Corporation	-
Model Name	TOPAZ-32D
TOPAZ-40D	TOPAZ-32D
TOPAZ-40D	Same as predicate
Appearance	Image: Basic type	Image	Yes, there is a difference
Collapsible type Column Stand
Option have been Added
Models have been tested
against International Safety and
EMC Standards. Any differences
between the subject device and
predicate device do not change
or add new potential safety risks
It is our determination that there
is "No negative impact on safety
or effectiveness" and there are
no new potential
or increased safety risks
concerning this difference
Same as predicate
	Image: Collapsible type
Indications
for Use	The 'TOPAZ Mobile X-ray System' is
intended for use in obtaining human
anatomical images of patients who
cannot be moved to the radiology
department for medical diagnosis.	The TOPAZ Mobile DR System, is a
mobile 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, bone density,
fluoroscopy and angiography
applications.	Same as predicate
The indications for use of the
previous TOPAZ Mobile DR
System and the current TOPAZ
Mobile X-ray System is
essentially the same.
The previous device described
the general intended use of
acquiring X-ray images of the
desired body part of the patient.
The current device emphasizes
the more specific situation of
acquiring images of immobile
patients.
Therefore, the intended use of
the two devices is essentially the
same, with only differences in
wording.
This device is not intended for
mammography, bone density,
fluoroscopy and angiography
applications.
These contraindications apply to
both the previous TOPAZ Mobile

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Image /page/9/Picture/0 description: The image contains a logo for "DRGEM Your Best Healthcare". The word "DR" is in black, and the word "GEM" is in teal. The words "Your Best Healthcare" are in a smaller font and are in black.

| | | | | | DR System and the current
TOPAZ Mobile X-ray System.
This matters are specified in the
warning and contraindication
sections on pages 13 and 18 of
the Operation Manual
(RMD1311-009) |
|--------------------------------|--------------------------------------|-------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1. High Frequency X- ray Generator | | | | |
| Output Power
Rating (kW) | 32kW | 40kW | 32kW | 40kW | |
| mA Range | Max. 400mA | Max. 500mA | Max. 400mA | Max. 500mA | Same as predicate |
| KV Range | 40 ~125 kV
(option: 150kV) | 40 ~ 125 kV
(option: 150kV) | 40 ~125 kV
(option: 150kV) | 40 ~ 125 kV
(option: 150kV) | |
| mAs Range | 0.1 ~500mAs | 0.1 ~500mAs | 0.1 500mAs | 0.1 500mAs | |
| | 2. X-ray tube housing Assembly | | | | |
| Configuration
model | E7239X / CANON | | E7239X / CANON | | |
| | E7242X / CANON | | E7242X / CANON | | |
| | E7299X / CANON | | E7299X / CANON | | |
| | E7876X / CANON | | E7876X / CANON | | |
| | E7884X / CANON | | E7884X / CANON | | |
| | DXT-8M / DRGEM | | DXT-8M / DRGEM | | |
| | DXT-11M / DRGEM | | DXT-11M / DRGEM | | |
| | DXT-10M / DRGEM | | DXT-10M / DRGEM | Same as predicate | |
| | DXT-12M / DRGEM | | DXT-12M / DRGEM | | |
| Focal spot | 1.0/2.0mm, | | 1.0/2.0mm, | | |
| | 0.3/1.0mm, | | 0.3/1.0mm, | | |
| | 0.6/1.2mm, | | 0.6/1.2mm, | | |
| | 0.6/1.5mm | | 0.6/1.5mm | | |
| Target angle | 12° to 16 | | 12° to 16 | | Yes, there is a difference.
The addition of the Collapsible
type Column Stand Option
adds a 330 degree column
rotation range. Models have
been tested against
International Safety and EMC
Standards. Any differences
between the subject device
and predicate device do not
change or add new potential
safety risks. It is our
determination that there is "No
negative impact on safety or
effectiveness" and there are
no new potential or increased
safety risks concerning this
difference |
| | depending upon the Tube | | depending upon the Tube | | |
| Colum
rotation
range | ± 325 degrees | | ± 325 degrees, | | |
| | ± 330 degrees | | | | |
| Tube
(Arm axis) | ± 180 degrees | | ± 180 degrees | | |
| Tube axis
rotation
range | -30+90 degrees | | -30+90 degrees | Same as predicate | |
| Max Tube
Voltage | 125kV, 150kV | | 125kV, 150kV | | |
| | 3. Collimator (Beam Limiting Device) | | | | |
| | Configuration
model | R108/R108F | R108/R108F | Yes, there is a difference.
Collimator Configuration
Models have been partially
deleted based on predicate
device. | |
| | | DXC-RML | DXC-RML/DXC-RMH | It is our determination that
there is "No negative impact on
safety or effectiveness" and
there are no new potential
or increased safety risks
concerning this difference | |
| | Lamp Type | LED lamp | LED and Halogen lamp | | |
| | 4. Solid State X-ray Imaging Device | | | | |
| | | - | PaxScan4336W / VAREX | There are differences between
the added detectors and the
original detector used in the
predicate device. All detectors
have been tested for
compatibility with TOPAZ via
internal testing and the added
detectors have been cleared by
FDA 510(k)s. It is our
determination that the added
detectors do not have a
negative impact on safety or
efficacy and there are no new
potential or increased safety
risks concerning these
differences. | |
| | Flat panel
Detector | PaxScan4336W v4/ VAREX | PaxScan4336W v4/ VAREX | | |
| | | XRpad2 3025 HWC-M / VAREX | XRpad2 3025 HWC-M / VAREX | | |
| | | XRpad2 4336 HWC-M / VAREX | XRpad2 4336 HWC-M / VAREX | | |
| | | XRpad2 4343 HWC-M / VAREX | XRpad2 4343 HWC-M / VAREX | | |
| | | Mano4336W / IRAY | Mano4336W / IRAY | | |
| | | Mano4343W / IRAY | Mano4343W / IRAY | | |
| | | 4343W / VAREX | - | | |
| | | Mars1417X / IRAY | - | | |
| | | Mars1717X / IRAY | - | | |
| | | Luna1012X / IRAY | - | | |
| | | F1417MCW / H&abyz | - | | |
| | | A1417MCW / H&abyz | - | | |
| | | A1717MCW / H&abyz | - | | |
| | 5. Imaging Processing Software | | | | |
| | Configuration
model | RADMAX | TPZ_IWS (XGRADMAX) | Yes, there is a difference. The
model name has been
changed. | |
| | Software
Version | 1.02 V | 1.00 V | see below difference | |
| | Horizontal Flip | Yes | Yes | Yes | |
| | Vertical Flip | Yes | Yes | Yes | |
| | Rotate
CW/CCW | Yes | Yes | Yes | |
| | Text Annotation | Yes | Yes | Yes | |
| | Ruler: Distance
too | Yes | Yes | Yes | |
| | Angle
measurement
tool | Yes | Yes | Yes | |
| | Zoom | Yes | Yes | Yes | |
| | Magnify | Yes | Yes | Yes | |
| | Image panning | Yes | Yes | Yes | |
| | Auto fitting to
window size | Yes | Yes | Yes | |
| | Image crop/cut | Yes | Yes | Yes | |
| | Image Copy | Yes | Yes | Yes | |
| | Recover the
original image | Yes | Yes | Yes | |
| | Window level
CD Burning | Yes | Yes | Yes | |
| | DICOM Print | Yes | Yes | Yes | |
| | Image Stitching | Yes | Yes | Yes | |
| | Image
Processing
Module | ·Module 1
·Module 2
·Module 3 | ·Module1 : IMFOU
·Module 2 : COV | Yes, there is a difference.
Models have been conducted
Verification activity. Any | |

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	·Module 4		differences between the
	· MODULE 1	· Module1: IMFOU	subject device and predicate
	Edge Enhancement: 0 ~ 50	Edge Enhancement: 0 ~ 50	device do not change or add
	Contrast Factor: 1 ~ 200	Contrast Factor: 1 ~ 200	new potential safety risks. It is
	Image Frequency: 0 ~ 20	Image Frequency: 0 ~ 20	our determination that there is
	Image Latitude: -10 ~ 10	Image Latitude: -10 ~ 10	"No negative impact on safety
or effectiveness" and there
	Sharpness: 0 ~ 100	Sharpness: 0 ~ 100	are no new potential
			or increased safety risks
	· MODULE 2	· Module 2 : COV	concerning this difference
	Histogram Optimization: -100 ~ 100	Histogram Optimization: -1 ~ 1(0.01
Step)
	Skin line Weight: -100 ~ 100	Skinline Weight: -1 ~ 1(0.01 Step)
	Latitude Compression: -100 ~ 100	Latitude Compression: -1 ~ 1(0.01 Step)
	Contrast Enhancement: -100 ~ 100	Contrast Enhancement: -1 ~ 1(0.01
Step)
	Edge Enhancement: -100 ~ 100	Edge Enhancement: -1 ~ 1(0.01 Step)
	Noise Suppression: -100 ~ 100	Noise Suppression: -1 ~ 1(0.01 Step)
	Gamma: -20 ~ 20	Gamma: -20 ~ 20
Specification
	· MODULE 3
	Global Brightness: -100 ~ 100
	Global Contrast: -100 ~ 100
	Latitude Compression: -100 ~ 100
	S-Structure Enhancement: -100 ~ 100
Noise Suppression: -100 ~ 100
	Gamma: -20 ~ 20

	· MODULE 4
	Global Brightness: -20 ~ 20
	Global Contrast: -30 ~ 30
	Local Contrast: 0 ~ 20
	Small Enhancement: 0 ~ 20
	Latitude Reduction: -20 ~ 20
	Noise Suppression: 0 ~ 20
	Gamma: -20 ~ 20

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VIII. SUMMARY OF NON-CLINICAL Data [21 CFR 807.92(b) (1)]

Nonclinical Testing:

The 'TOPAZ Mobile X-ray System', has been assessed and tested and has passed predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the subject device and followed the process documented in the System Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

| Std | Safety/EMC Standards Description | FDA Rec.
Standard |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| IEC 60601-1 | Medical electrical equipment, Part 1: General requirements for basic safety and essential
performance | 19-46 |
| 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. | 19-36 |
| IEC 60601-1-3 | Medical electrical equipment
Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment | 12-336 |
| IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability | 5-132 |
| 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 | 12-309 |
| 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 | 12-348 |
| IEC 62304:2006 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
Medical device software - Software life cycle processes | 13-79 |
| ISO 14971:2019 | ISO 14971:2019 Third Edition, Medical devices - Applications of risk management to medical
devices. | 5-125 |
| ISO 15223-1 | ISO 15223-1 Fourth Edition 2021-07, Medical devices - Symbols to be used with medical
device labels, labelling, and information to be supplied - Part 1: General requirements. | 5-134 |
| NEMA PS 3.1 -
3.20 (2016). | NEMA PS 3.1 - 3.20 (2022). Digital Imaging and Communications in Medicine (DICOM) Set
DICOM Standard. | 12-349 |
| 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 (2005) | 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 |

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Image /page/13/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.

| TR 60601-4-2 | TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and
interpretation - Electromagnetic immunity: performance of medical electrical equipment and
medical electrical systems | 19-19 |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| FDA Guidance | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications
dated November 28, 2017 | |
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s, Guidance for Industry and Food and Drug Administration
Staff, Document issued on September 13, 2019. | |
| FDA Guidance | Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices dated September 1, 2016 | |
| FDA Guidance | Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug
Administration Staff Document issued on June 14, 2023. | |
| FDA Guidance | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
contained in Medical Devices, Document issued on: May 11, 2005 | |
| FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Guidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023. | |

Summary:

Based on the performance as documented in the V&V Testinq, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device.

The following International Standards were used to develop and verify electrical safety, and EMC. 'TOPAZ Mobile X-ray System' has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports).

The subject device conforms to all applicable requirements of 21 CFR 1020.30-31

IX. CONCLUSIONS [21 CFR 807.92(b) (3)]

The 510(k) Pre-Market Notification for 'TOPAZ Mobile 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.