NFLK-2501 Portable X-ray Unit

K211383 · Neuf, Inc. · IZL · Aug 13, 2021 · Radiology

Device Facts

• Record ID: K211383
• Device Name: NFLK-2501 Portable X-ray Unit
• Applicant: Neuf, Inc.
• Product Code: IZL · Radiology
• Decision Date: Aug 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Portable X-ray unit for diagnostic imaging; inputs include user-selected kV and mAs parameters via control panel; system control board manages high-voltage tank to excite X-ray tube; produces X-ray radiation for image acquisition; used in mobile or fixed clinical sites by physicians or technicians; handheld or stand-mounted operation; output used by healthcare providers for diagnostic decision-making; benefits include compact, lightweight design for flexible clinical imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, and IEC 60601-2-54 standards, alongside 21 CFR 1020.30 performance standards for ionizing radiation-emitting products.

Technological Characteristics

Mains-powered mobile X-ray system; 50 kHz HF generator; 2.5 kW output; 40-100 kVp range; 1.2 mm focal spot X-ray tube; LED display with pushbuttons; 8 memory settings; compatible with flat-panel detectors (Rayence/Vieworks); stand-mounted or handheld; cybersecurity controls implemented; conforms to IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54.

Indications for Use

Indicated for use by qualified physicians or technicians to acquire X-ray images of head, cervical spine, chest, abdomen, lumbar spine, pelvis, and extremities in adult and pediatric patients. Handheld use limited to extremities. Stand-mounted use excludes chest imaging unless performed without a grid. Not for mammography.

Regulatory Classification

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.

Predicate Devices

• MinXray, Model HF120/60H PowerPlus (K040046)

Reference Devices

• RAYENCE 1717/SGC (K171419)
• RAYENCE 1717/SCC (K171420)
• VIEWORKS VIVIX-S 1717V (K181003)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K211383

Device Name NFLK-2501 Portable X-ray Unit

#### Indications for Use (Describe)

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.

| 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)

#### 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."

{3}------------------------------------------------

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

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 : [phone], Fax : [phone] E-mail: [e-mail]

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

{4}------------------------------------------------

Image /page/4/Picture/0 description: This image contains a logo on the left, the text "005 510(k) Summary" in the center, and the text "Page: 005-2" on the right. The logo appears to be a stylized graphic. The text is arranged horizontally across the image.

Regulatory Class: Class II Product Code: IZL

## IV. 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

{5}------------------------------------------------

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.

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).

## V. INDICATIONS FOR USE

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.

# 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.

{6}------------------------------------------------

| 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/trained<br>physician or technician on both adult and pediatric subjects for<br>taking diagnostic x-rays. Not for mammographic use. | The NFLK-2501 Mobile X-ray System is intended for use by a<br>qualified/trained physician or technician for the purpose of acquiring<br>X-ray images of the desired parts of patient's anatomy (including head,<br>cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).<br>The system may be used for handheld diagnostic imaging of body<br>extremities.<br>The system is subject to the following limitations of use when stand<br>mounted:<br>- The device may be used for diagnostic imaging of head, cervical<br>spine, abdomen, lumbar spine, pelvis or extremities.<br>- The device may be used for imaging of the chest when used<br>without a grid.<br>This system is not intended for mammography. | | |
| Weight | 17.94 kg | 11.5 kg | | |
| Size | 453*292*224 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 time<br>selections with LED indicators mAs indicator | Pushbuttons with LED indicators | | |
| Exposure time | (0.01-0.2sec) in 0.01sec. Step<br>(0.2-0.4sec) in 0.02sec. Step<br>(0.4-1.0sec) in 0.05sec Step<br>(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,<br>0.01~1.3, 2.0~4.0) sec | | |
| Memory Settings<br>(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 or<br>1717/SCC declared in K171420<br>VIEWORKS VIVIX-S 1717V declared in K181003 | | |
| Flat-panel<br>detector<br>specifications | None | 1717/SGC: 127u 3,328 x 3,328 pixels<br>1717/SCC: 127u 3,328 x 3,328 pixels<br>VIVIX-S 1717V: 140u 3072 x 3072 pixels | | |

{7}------------------------------------------------

{8}------------------------------------------------

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.

{9}------------------------------------------------

### VII. Non-clinical testing:

| IEC 60601-1:2005/AMD1:<br>2012<br>EN 60601-1:2006/A1:2013 | Medical electrical equipment -- Part 1: General<br>requirements for basic safety and essential performance |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2014 /<br>EN60601-1-2:2015 | Medical electrical equipment – Part 1-2: General<br>requirements for basic safety and essential performance<br>– Collateral standard: Electromagnetic disturbances –<br>Requirements and tests |
| EN 60601-1-3:2008/<br>A11:2016 | Medical electrical equipment - Part 1-3: General<br>requirements for basic safety and essential performance<br>- Collateral Standard: Radiation protection in diagnostic<br>X-ray equipment (IEC 60601-1-3:2008) |
| IEC 60601-2-54:2015/<br>EN 60601-2-54:2015 | Medical electrical equipment -- Part 2-54: Particular<br>requirements for the basic safety and essential<br>performance of X ray equipment for radiography and<br>radioscopy |

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

{10}------------------------------------------------

#### 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.