The NFLK-2501 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted:

The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

Device Description

The NFLK-2501 consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator. A cart or a stand can be used with the NFLK-2501. In addition, this unit has preset memory keys to store and select kV. The NFLK-2501 is used with a flat-panel detector.

This device is a mains-powered Mobile X-ray System, designed and manufactured by NEUF.

Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.

The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), and system control software running on the SYS board. The system control software is for realtime interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators.

The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.

This device is not intended for mammography.

The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. The NFLK-2501 is designed for handheld or stand-mounted imaging. The NFLK-2501 can be configured to an optional portable stand/rack (see optional stands in 4.2) or use a stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.

The cybersecurity risks of the NFLK-2501 have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).

AI/ML Overview

The provided FDA 510(k) summary for the NFLK-2501 Portable X-ray Unit primarily focuses on establishing substantial equivalence to a predicate device through technological comparison and compliance with electrical safety and performance standards. It does not present acceptance criteria or a study proving the device meets specific clinical performance criteria in the way typically seen for AI/ML-based devices.

The document is for a traditional X-ray unit, not an AI-powered diagnostic device. Therefore, the types of acceptance criteria and studies anticipated for AI/ML devices (e.g., sensitivity, specificity, AUC, MRMC studies) are not applicable or detailed here.

Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed, which focuses on device safety, electrical performance, and compliance with general X-ray standards to demonstrate substantial equivalence.

Here's the information based on the provided document, interpreting "acceptance criteria" as compliance with relevant standards and "study" as the non-clinical testing performed:

Acceptance Criteria and Study for NFLK-2501 Portable X-ray Unit

The NFLK-2501 Portable X-ray Unit is a traditional X-ray device, and its acceptance criteria are primarily based on demonstrating substantial equivalence to a predicate device and compliance with established electrical safety, performance, and radiation protection standards. The "study" refers to the non-clinical bench testing conducted to meet these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Standards)	Reported Device Performance
Safety and Essential Performance (IEC 60601-1:2005/AMD1:2012)	Testing performed successfully according to IEC 60601-1:2005/AMD1:2012 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance).
Electromagnetic Disturbances (IEC 60601-1-2:2014)	Testing performed successfully according to IEC 60601-1-2:2014 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests).
Radiation Protection in Diagnostic X-ray Equipment (EN 60601-1-3:2008)	Testing performed successfully according to EN 60601-1-3:2008 (Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment).
Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy (IEC 60601-2-54:2015)	Testing performed successfully according to IEC 60601-2-54:2015 (Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy).
Compliance with Specific Guidance Documents	All applicable aspects of listed guidance documents addressed (e.g., "The Content of Premarket Submissions for Software Contained in Medical Devices," "Guidance for the Submission of 510(k) for Solid State X-ray Imaging devices," "Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance," "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices").
Compliance with Ionizing Radiation Emitting Products Regulations (21 CFR 1020 Subchapter J & 21 CFR 1020.30)	Device conforms to 21 CFR 1020 Subchapter J (Performance Standards for Ionizing Radiation Emitting Products) and 21 CFR 1020.30 (Diagnostic x-ray system and their major components).
Cybersecurity Risk Management	Cybersecurity risks addressed to assure no new or increased risks were introduced, as per device risk analysis and controls implemented.
Substantial Equivalence to Predicate Device (MinXray HF120/60HPowerPlus™)	The device is deemed as safe and effective as the predicate device, with the same indications for use and minor technological differences addressed through performance testing and standard compliance.

2. Sample size used for the test set and the data provenance

This is a traditional X-ray unit, not an AI/ML diagnostic device that relies on a "test set" of images or patient data for performance evaluation. The "testing" involved non-clinical bench tests to verify compliance with electrical, mechanical, and radiation safety standards. Therefore, the concept of a "sample size for a test set" and "data provenance" in the context of clinical performance data is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is not an AI/ML diagnostic device with a clinical "test set" requiring ground truth establishment, no experts were involved in this capacity. The "ground truth" for the device's acceptable performance is defined by compliance with the referenced industry and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a portable X-ray unit, which is a hardware device for image acquisition, not an AI/ML-driven diagnostic aid for image interpretation. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an X-ray imaging system, not an algorithm, and does not have a standalone "algorithm-only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the successful demonstration of compliance with established international medical device standards (e.g., IEC 60601 series) and FDA regulations (21 CFR 1020). These standards define acceptable levels of safety, electrical performance, and radiation characteristics for X-ray equipment. It is not based on clinical "ground truth" such as pathology or outcomes data for diagnostic accuracy, as this is an imaging device, not a diagnostic algorithm.

8. The sample size for the training set

Not applicable. The device is a hardware X-ray machine, not an AI/ML model trained on a dataset.

9. How the ground truth for the training set was established

Not applicable for the reasons stated above.

Summary

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August 13, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

NEUF Inc. % Woo Sung Park Consultant MEDMONTS Co., Ltd. Life-officetel 320, 40, 63-ro, Youngdeungpo-gu Seoul, 07345 REPUBLIC OF KOREA

Re: K211383

Trade/Device Name: NFLK-2501 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: April 26, 2021 Received: May 17, 2021

Dear Woo Sung Park:

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

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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 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 (OS) 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Laurel M. Burk -S. The date of the signature is 2021.08.13, and the time is 10:00:20 -04'00'.

. 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211383

Device Name NFLK-2501 Portable X-ray Unit

Indications for Use (Describe)

The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted:

The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image: NEUF logo	005_510(k) Summary	Page:	005-1
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005_510(k) Summary

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

The assigned 510(k) Number: K211383

I. SUBMITTER

NEUF Inc.

Address: #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si, Jeollanam-do, Republic of Korea (zip : 58034)

Tel : +82-61-740-2830, Fax : +82-31-755-1915 E-mail: ehjung@neufgen.com

Person: Eun Ho Jung

Position: RA/QA

Date Prepared: Apr.24, 2021

II. DEVICE

Name of Device: NFLK-2501 Portable X-ray Unit Regulation Name: Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulatory Class: Class II Product Code: IZL

III. PREDICATE DEVICE

Manufacturer: MinXray, Inc. Name of Device: MinXray, Model HF120/60H PowerPlus 510(k) number: K040046 Regulation Name: Mobile X-ray System Regulation Number: 21 CFR 892.1720

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Regulatory Class: Class II Product Code: IZL

IV. DEVICE DESCRIPTION

This device is a mains-powered Mobile X-ray System, designed and manufactured by NEUF.

Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.

The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.

This device is not intended for mammography.

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Image /page/5/Picture/0 description: The image contains the word "NEUF" in bold, sans-serif font. To the left of the word is a stylized logo. The logo is a geometric shape with four triangular sections, colored gray, pink, and blue.

can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.

V. INDICATIONS FOR USE

The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted:

The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The comparison between the overall specifications of predicate device (MinXray HF120/60HPowerPlus™) and the subject device (NFLK-2501 mobile X-ray system) is shown in Table 1.

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NEUF	005_510(k) Summary		Page:	005-4
Table 1 Comparison of Technology Characteristics
Item	Predicate Device	Subject Device
	MinXray HF120/60HPowerPlus™ (K040046)	NFLK-2501 (without digital imaging)
Indications for use	This radiographic system is intended for use by a qualified/trainedphysician or technician on both adult and pediatric subjects fortaking diagnostic x-rays. Not for mammographic use.	The NFLK-2501 Mobile X-ray System is intended for use by aqualified/trained physician or technician for the purpose of acquiringX-ray images of the desired parts of patient's anatomy (including head,cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).The system may be used for handheld diagnostic imaging of bodyextremities.The system is subject to the following limitations of use when standmounted:- The device may be used for diagnostic imaging of head, cervicalspine, abdomen, lumbar spine, pelvis or extremities.- The device may be used for imaging of the chest when usedwithout a grid.This system is not intended for mammography.
Weight	17.94 kg	11.5 kg
Size	453292224 mm	365 * 190 * 185 mm
Output	60 mA(0.01-0.1sec), 42 mA (0.11 – 5.0sec) @ 40 - 50 kVDC	40~~50kV/51~~60kV/61~~70kV/71~~80kV: 30mA
	50 mA(0.01-0.1sec), 35 mA (0.11 – 5.0sec) @ 52 - 60 kVDC	61~70kV: 35mA
	45 mA(0.01-0.1sec), 31.5 mA (0.11 – 5.0sec) @ 62 - 70 kVDC	71~~80kV/81~~90kV/91~100kV: 25mA
	38 mA(0.01-0.1sec), 26.6 mA (0.11 - 5.0sec) @ 72 - 80 kVDC	81~~90KV/91~~100kV: 20mA
	33 mA(0.01-0.1sec), 23.1 mA (0.11 – 5.0sec) @ 82 - 90 kVDC
	30 mA(0.01-0.1sec), 21 mA (0.11 – 5.0sec) @ 92 - 100 kVDC
	20 mA(0.01-0.1sec), 14 mA (0.11 – 5.0sec) @ 102 - 120 kVDC
NEUF	005_510(k) Summary		Page:	005-5
Use Interface	Up-Down pushbuttons for kVp selections and exposure timeselections with LED indicators mAs indicator	Pushbuttons with LED indicators
Exposure time	(0.01-0.2sec) in 0.01sec. Step(0.2-0.4sec) in 0.02sec. Step(0.4-1.0sec) in 0.05sec Step(1.0-5.0sec) in 0.1sec Step	(0.01~~4.0, 0.01~~1.8, 2.7~~3.3, 0.01~~1.7, 2.5~~3.2, 0.01~~1.6, 2.5~~4.0,0.01~~1.3, 2.0~4.0) sec
Memory Settings(technique)	5 memories	8 memories
HF Generator	85 kHz	50 kHz
kW	2.4 kW peak	2.5 kW
kVp	40-120 kVp	40-100 kVp
X-ray Tube	Superior X-ray Tube Company SXR-130 1.2 mm, 65 kHU	D-125 CANON(TOSHIBA) & OX/125-1.2(CEI) 1.2mm, 35kHU
Collimator	Advantech	DGI
Flat-panel detector	None	Either RAYENCE 1717/SGC declared in K171419 or1717/SCC declared in K171420VIEWORKS VIVIX-S 1717V declared in K181003
Flat-paneldetectorspecifications	None	1717/SGC: 127u 3,328 x 3,328 pixels1717/SCC: 127u 3,328 x 3,328 pixelsVIVIX-S 1717V: 140u 3072 x 3072 pixels

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Image /page/8/Picture/2 description: The image contains two photos of a MINXRAY HF120/60HPPWV PowerPlus portable X-ray machine. The photo on the left shows the machine from a front three-quarters perspective, highlighting its yellow and black color scheme, control knobs, and collimator. The photo on the right shows the machine from a top-down perspective, with a blue circle drawn around it.

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VII. Non-clinical testing:

IEC 60601-1:2005/AMD1:2012EN 60601-1:2006/A1:2013	Medical electrical equipment -- Part 1: Generalrequirements for basic safety and essential performance
IEC 60601-1-2:2014 /EN60601-1-2:2015	Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essential performance– Collateral standard: Electromagnetic disturbances –Requirements and tests
EN 60601-1-3:2008/A11:2016	Medical electrical equipment - Part 1-3: Generalrequirements for basic safety and essential performance- Collateral Standard: Radiation protection in diagnosticX-ray equipment (IEC 60601-1-3:2008)
IEC 60601-2-54:2015/EN 60601-2-54:2015	Medical electrical equipment -- Part 2-54: Particularrequirements for the basic safety and essentialperformance of X ray equipment for radiography andradioscopy

Testing was performed successfully according to the following standards:

Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:

. "The Content of Premarket Submissions for Software Contained in Medical Devices"
. "Guidance for the Submission of 510(k) for Solid State X-ray Imaging devices"
. Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 2005
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 2018

All applicable aspects of these guidance documents listed in this 510(k) summary have been addressed. The device also conforms to the following:

· 21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products
· 21 CFR 1020.30: Diagnostic x-ray system and their major components

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CONCLUSIONS VIII.

After analyzing bench tests, it is the conclusion of NEUF Inc. that the NFLK-2501 Portable X-ray Unit is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.

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.