XLITE
Device Facts
| Record ID | K260236 |
|---|---|
| Device Name | XLITE |
| Applicant | GEMSS HEALTHCARE CO., LTD. |
| Product Code | IZL · Radiology |
| Decision Date | Aug 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1720 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The XLITE is a mobile diagnostic X-ray system intended for stand-mounted use by qualified and trained healthcare professionals to produce diagnostic radiographic images of the extremities in adult patients. The device is intended for extremity imaging only. The device is not intended for mammography.
Device Story
Battery-powered portable X-ray system; comprises high-voltage generator, X-ray tube assembly, adjustable collimator, internal battery, operation panel. Operates by generating X-ray beam in tube; beam passes through patient; tissues attenuate photons based on density. Used in professional healthcare environments; operated by qualified healthcare professionals. System produces diagnostic radiographic images when used with compatible external imaging detectors. Output parameters (peak voltage, tube current) controlled via operation panel; affects clinical decision-making by providing diagnostic-quality images of extremities. Benefits patient through portable, stand-mounted extremity imaging capability.
Clinical Evidence
Bench testing confirmed compliance with loading factor accuracy, radiation output reproducibility, and image quality (MTF, DQE, NPS, linearity, lag, uniformity). Clinical image evaluation by qualified experts demonstrated diagnostic-quality radiographs of adult extremities.
Technological Characteristics
Mobile X-ray system; inverter generator; battery/AC powered. Focal spot 0.8mm/0.4mm; max power 500W/420W; peak voltage 90kV/80kV; tube current 5-10mA/5-8mA. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-2. Standalone embedded system; no network/internet connectivity. Sterilization not applicable.
Indications for Use
Indicated for diagnostic radiographic imaging of extremities in adult patients. Intended for stand-mounted use by qualified, trained healthcare professionals. Contraindicated 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
- ADX6000 (K143494)
Submission Summary (Full Text)
{0}
**U.S. FOOD & DRUG**
ADMINISTRATION
August 3, 2026
GEMSS HEALTHCARE CO., LTD.
% Dave Yungvirt
CEO
Third Party Review Group, LLC
1887 Whitney Mesa Dr. Suite 1960,
HENDERSON, NV 89014
Re: K260236
Trade/Device Name: XLITE
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile X-Ray System
Regulatory Class: Class II
Product Code: IZL
Dated: April 15, 2026
Received: April 21, 2026
Dear Dave Yungvirt:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K260236 - Dave Yungvirt
Page 2
(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-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).
{2}
K260236 - Dave Yungvirt
Page 3
Sincerely,
Lu Jiang
, for
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K260236
Device Name
XLITE
Indications for Use (Describe)
The XLITE is a mobile diagnostic X-ray system intended for stand-mounted use by qualified and trained healthcare professionals to produce diagnostic radiographic images of the extremities in adult patients. The device is intended for extremity imaging only. The device is not intended for mammography.
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 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
GEMSS
Healthcare
K260236
510(k) Summary
# 510(k) Summary
This summary of 510(k) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: August 3, 2026
## 1 Applicant / Submitter
- GEMSS HEALTHCARE CO., LTD.
- Address: 1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952, Republic of Korea
- Tel: +82-31-906-9017 Fax: +82-31-906-9019
- Submitter: Jeongbin Park Email:bin5754@gemss.co.kr
## 2 Device Information
- Trade/Device Name: XLITE
- K Number: K260236
- Regulation Number: 21CFR 892.1720
- Regulation Name: Mobile X-Ray System
- Device Class: Class II
- Product Code: IZL
## 3 Predicate Device
- K Number: K143494
- Manufacturer: DEXCOWIN
- Trade Name: ADX6000
## 4 General Description
The XLITE is a battery-powered portable X-ray system composed of a high-voltage generator, an X-ray tube assembly, an adjustable collimator, an internal battery, and an operation panel.
During operation, the system generates an X-ray beam in the X-ray tube and transmits it through the patient. As the beam passes through the body, tissues attenuate the photons according to their density.
## 5 Indication for use
The XLITE is a mobile diagnostic X-ray system intended for stand-mounted use by qualified and trained healthcare professionals to produce diagnostic radiographic images of the extremities in adult patients. The device is intended for extremity imaging only. The device is not intended for mammography.
1
{5}
GEMSS
Healthcare
510(k) Summary
6 Comparison of the modified device to the cleared device
| No. | Item | Proposed device | Predicate device | Note |
| --- | --- | --- | --- | --- |
| 1 | K Number | K260236 | K143494 | - |
| 2 | Manufacturer | GEMSS Healthcare | DEXCOWIN | - |
| 3 | Trade Name | XLITE | ADX6000 | - |
| 4 | Product Code | IZL | IZL | Identical |
| 5 | Regulation Number | 21 CFR 892.1720 | 21 CFR 892.1720 | Identical |
| 6 | 510(k) Review Panel | RADIOLOGY | RADIOLOGY | Identical |
| 7 | Indications for Use | The XLITE is a mobile diagnostic X-ray system intended for stand-mounted use by qualified and trained healthcare professionals to produce diagnostic radiographic images of the extremities in adult patients. The device is intended for extremity imaging only. The device is not intended for mammography. | The ADX6000 is a handheld and portable general purpose X-ray system. The device uses a variable tube current with voltage from 50-80 kV and, therefore, is limited to taking diagnostic x-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. This device is not intended for mammography. | Identical |
| 8 | Configuration | Line operated portable | Line operated portable | Identical |
| 9 | Generator Type | Inverter | Inverter | Identical |
| 10 | Focal spot | 0.8mm / 0.4mm | 0.8mm | Identical |
| 11 | Max Power Output | 500W / 420W | 400W | Similar |
| 12 | Peak Voltage | 90kV / 80kV | 80 kV | Similar |
| 13 | Tube Current | 5-10mA / 5-8mA | 1-5mA | Similar |
| 14 | Power Source | AC Line, DC Battery 100-240V AC, DC 22.2-25.2V | AC Line, DC Battery 100-220V AC, DC 18.5-21V | Identical |
1) Differences Between the Subject and Predicate Devices
The XLITE is substantially equivalent to its predicate device, the ADX6000, in design concept, technological characteristics, and intended use. Both devices are portable X-ray generators intended for use by qualified healthcare professionals in professional healthcare environments and are limited to taking diagnostic X-ray exposures of extremities.
The XLITE operates based on the same fundamental principles as the predicate device, generating X-ray radiation that passes through the patient and is captured by an external imaging system to produce a diagnostic image.
The electrical safety, EMC, and performance characteristics of the XLITE have been evaluated in accordance with applicable standards, and the software has been validated. The overall output characteristics—including peak voltage, tube current ranges, exposure parameters, and dose output—are comparable to those of the predicate device. These similarities demonstrate that the technological characteristics do not raise new performance concerns. Both devices conform to applicable EPRC performance standards.
2
{6}
GEMSS
Healthcare
510(k) Summary
The primary differences between the XLITE and the predicate device relate to product design and performance ranges, including form factor, mechanical configuration, and output specifications such as peak voltage, tube current, and power output. These differences do not affect the device's intended use, fundamental operating principles, or essential performance, as confirmed through performance testing and risk management activities.
No new or different questions of safety or effectiveness are raised as a result of these differences. Therefore, the XLITE is substantially equivalent to the ADX6000.
## 7 Software
The primary function of the software is the operation of X-ray equipment for image acquisition. The user operates the X-ray Operation Unit to control the X-ray Control Unit. In X-ray Operation Unit, user can use Power On / Off, X-ray setting, irradiation, and options of X-ray Control Unit. The X-ray control unit carries out the X-ray setting and irradiation with the information transmitted from the X-ray operation.
The firmware does not store user or patient information. The XLITE is a standalone embedded system with no wired or wireless network connectivity, Internet connectivity, removable media, or user-accessible data interface. The external charging connector is limited to power transfer, and data communication is physically disabled. Firmware is programmed through a controlled internal manufacturing interface before final enclosure assembly, and the interface is inaccessible in the final commercial device. End users and service personnel cannot update the firmware in the field. If a post-distribution firmware change is required, the affected device is returned through the manufacturer's controlled RMA process.
The software validation report was prepared in accordance with "FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
## 8 Electrical Safety and Electromagnetic Compatibility
Electrical safety was evaluated against the applicable FDA-recognized consensus standards:
- IEC 60601-1
- IEC 60601-1-3
- IEC 60601-2-54
Electromagnetic compatibility (EMC) was evaluated against the applicable FDA-recognized consensus standard:
- IEC 60601-1-2
The subject device declares conformity to the above standards in accordance with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices."
## 9 Testing
3
{7}
GEMSS Healthcare
510(k) Summary
Bench testing confirmed compliance with loading factor accuracy, radiation output reproducibility, and image quality requirements (MTF, DQE, NPS, linearity, lag, uniformity).
Clinical image evaluation by qualified clinical experts demonstrated diagnostic-quality radiographs of adult extremities can be captured using the subject device when used as intended with compatible detectors.
## 10 Conclusion
The comparison of the intended use and technological characteristics demonstrates that the XLITE is at least as safe and effective as the predicate device, ADX6000 (K143494). Differences in specifications—such as maximum output power and tube current range—do not raise new questions of safety or effectiveness. Performance testing, electrical safety, EMC testing, and software validation confirm that the XLITE performs as intended under the specified use conditions. Therefore, GEMSS Healthcare concludes that the XLITE is substantially equivalent to the predicate device.
4
