INNOVISION-DXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-DXII is not intended for mammography, angiography, interventional, or fluoroscopy use.

Device Description

INNOVISION-DXII is a stationary X-ray system using single and three phase power and consists of Tube, HVG(High voltage generator), Ceiling suspended X-ray tube support, Floor to Ceiling X-ray tube support, patient table, detector stand, and X-ray control console. The X-ray control console is a window-based software that can view X-ray images and a mobile console mounted on an Android-based board that only controls X-rays without viewer function.

After turning on the control unit, it irradiates the set X-ray on the exposure position properly generating X-ray in the inverter generator using IGBT. The compositions like supporters for X-ray tube and tables are used to supply power from the High Voltage generator. When inverter type of Generator creates X-ray irradiation by certain exposure conditions, and X-ray penetrates the patient's body. X-ray information is transferred to a visible ray by a sensor's scintillator, and it turns to an electric signal through A-Si after transmitting photodiode to a TFT Array. This X-ray system is used with FDA cleared X-ray detectors. The electric signal is magnified and turned into a digital signal to create image data. The image is transferred to the PC display by an Ethernet Interface, and it can be adjusted.

AI/ML Overview

The FDA 510(k) clearance letter for INNOVISION-DXII explicitly states that clinical testing was not performed for this device. Therefore, there is no study described within this document that proves the device meets acceptance criteria related to clinical performance or human reader studies.

The provided document focuses on non-clinical performance tests to demonstrate substantial equivalence to the predicate device.

Here's an analysis based on the information provided, outlining what is and isn't available regarding acceptance criteria and studies:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for the INNOVISION-DXII are implicitly the successful completion of the bench tests according to recognized international standards and demonstration that the differences from the predicate device do not raise new safety or effectiveness concerns. The "reported device performance" is the successful passing of these tests, indicating the device is safe and effective in its essential functions.

Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing)

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
X-ray Tube, Collimator, HVG	Tube Voltage accuracy	Meet specified accuracy standards (e.g., within a tolerance)	Passed
	Accuracy of X-RAY TUBE CURRENT	Meet specified accuracy standards	Passed
	Reproducibility of the RADIATION output	Meet specified reproducibility standards	Passed
	Linearity and constancy in RADIOGRAPHY	Meet specified linearity and constancy standards	Passed
	Half Value Layer (HVL) / Total filtration	Meet specified HVL/filtration standards	Passed
	Accuracy of Loading Time	Meet specified loading time accuracy	Passed
Detector	System Instability	No unacceptable system instability observed	Passed
	Installation error	No unacceptable installation errors	Passed
	System Error	No unacceptable system errors	Passed
	Image Loss, Deletion, and Restoration	Proper handling of image loss, deletion, and restoration	Passed
	Image Save Error	No unacceptable image save errors	Passed
	Image Information Error	No unacceptable image information errors	Passed
	Image Transmission and Reception	Reliable image transmission and reception	Passed
	Header Verification	Correct header verification	Passed
	Security	Meet specified security requirements	Passed
	Image Acquisition Test	Successful image acquisition	Passed
	Search Function	Functional search capability	Passed
	Application Function (ELUI S/W)	Functional application software	Passed
	Resolution	Meet specified resolution standards	Passed
Mechanical Components (Support, Table)	Moving distance	Accurate and controlled movement within specifications	Passed

Study Details for Demonstrating Substantial Equivalence (Non-Clinical)

The study described is a series of bench tests (functional tests) conducted to ensure the safety and essential performance effectiveness of the INNOVISION-DXII X-ray system.

Sample size used for the test set and data provenance:
- Sample Size: Not applicable. These are functional tests of the device itself rather than tests on a dataset. The "sample" refers to the physical device components and the system as a whole.
- Data Provenance: Not applicable in the context of image data. The tests are performed on the device in a laboratory setting. The standards referenced are international (IEC).
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. Ground truth in this context refers to the expected functional performance of the device according to engineering specifications and regulatory standards (IEC 60601 series). These standards define the "ground truth" for electrical safety, mechanical performance, and radiation emission/accuracy. Experts are involved in conducting and interpreting these standardized tests, but there isn't a "ground truth" established by a panel of medical experts as there would be for image interpretation.
Adjudication method for the test set:
- Not applicable. The tests are typically pass/fail based on objective measurements against predefined thresholds specified in the IEC standards. There is no subjective adjudication process mentioned.
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:
- No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical testing is not performed for the subject device as the detectors were already 510(k) cleared and the imaging software (Elui) is the same as the predicate device. There were no significant changes." This device is a stationary X-ray system, not an AI-assisted diagnostic tool for image interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is an X-ray imaging system; it does not feature a standalone diagnostic algorithm. While it includes an imaging software (Elui), its performance is assessed as part of the overall system's image acquisition and processing capabilities, not as an independent diagnostic algorithm.
The type of ground truth used:
- For the non-clinical bench tests, the "ground truth" is defined by the engineering specifications and the requirements of the referenced international standards (IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54). These standards specify acceptable ranges for parameters like tube voltage accuracy, radiation output linearity, image resolution, and system stability.
The sample size for the training set:
- Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set of data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary of Clinical/AI-related information:
The FDA 510(k) clearance for INNOVISION-DXII does not include any clinical studies or evaluations of AI performance, human reader performance, or diagnostic accuracy. The clearance is based purely on the non-clinical bench testing demonstrating that the device meets safety and essential performance standards and is substantially equivalent to its predicate device for obtaining radiographic images.

Summary

FDA 510(k) Clearance Letter - INNOVISION-DXII

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August 1, 2025

DK MEDICAL SYSTEMS Co., Ltd
℅ Dongha Lee
RA Consultant
KMC, Inc
#1709, G-Plus Tower, 123, Digital-ro 26-gil, Guro-gu
SEOUL, 08390
SOUTH KOREA

Re: K250790
Trade/Device Name: INNOVISION-DXII
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary X-Ray System
Regulatory Class: Class II
Product Code: KPR
Dated: March 14, 2025
Received: July 11, 2025

Dear Dongha Lee:

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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K250790 - Dongha Lee Page 2

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 (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 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-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-

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K250790 - Dongha Lee Page 3

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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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): K250790

Device Name: INNOVISION-DXII

Indications for Use (Describe):

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

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510(k) Summary

510(k) #: K250790
Prepared on: 2025-07-24

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	DK MEDICAL SYSTEMS Co., Ltd
Applicant Address	52, Chupalsandan 1-Gil, Paengseong-Eup Pyeongtaek-Si Gyeonggi-do 17998 Korea, South
Applicant Contact Telephone	82-2-535-7231
Applicant Contact	Mr. Sung-moon Hong
Applicant Contact Email	smhong@dk.co.kr
Correspondent Name	KMC, Inc
Correspondent Address	#1709, G-Plus Tower, 123, Digital-ro 26-gil, Guro-gu Seoul 08390 Korea, South
Correspondent Contact Telephone	82-70-8965-5554
Correspondent Contact	Mr. DongHa Lee
Correspondent Contact Email	dhlee@kmcerti.com

Device Name

21 CFR 807.92(a)(2)

Field	Information
Device Trade Name	INNOVISION-DXII
Common Name	Stationary x-ray system
Classification Name	Stationary X-Ray System
Regulation Number	892.1680
Product Code(s)	KPR

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K242119	INNOVISION-EXII	KPR

Device Description Summary

21 CFR 807.92(a)(4)

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digital signal to create image data. The image is transferred to the PC display by an Ethernet Interface, and it can be adjusted.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

Indications for use is the same as the predicate device (K242119)

Technological Comparison

21 CFR 807.92(a)(6)

The subject device has the same operation principle to generate x-ray and clinical imaging.

The following technological characteristics exist between the subject device and the predicate device.

Operator console: X-ray control console that controls the subject device is operated by Android-based GUI software.
High Voltage Generator: The specifications (input line voltage and maximum output power) of the subject device is different from the predicate device. The line voltage is depending upon the system requirement.
X-ray tube: A used x-ray tube model (RAD-14) is the same as the predicate device.

The other used x-ray tube models (E7239X, E7884X) of the subject device are different from the predicate device.

Collimator: The used collimator models of the subject device are different from the predicate device.
Detector: The subject device uses FDA cleared X-ray detectors. Some detector models were different from the predicate device. The detectors were verified about compatibility with the subject device.

The differences have been verified about the safety and performance by FDA recognized standards. The test results show that the differences did not raise new safety and effectiveness concerns.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Performance tests were performed with the follow consideration.

Bench testing (Functional test) according to IEC 60601-1-3, IEC 60601-2-28 and IEC 60601-2-54.

For X-ray Tube, Collimator and High Voltage Generator
- a) Tube Voltage accuracy
- b) Accuracy of X-RAY TUBE CURRENT
- c) Reproducibility of the RADIATION output in RADIOGRAPHY
- d) Linearity and constancy in RADIOGRAPHY
- e) Half Value Layer(HVL) / Total filtration
- f) Accuracy of Loading Time
For Detector
- a) System Instability
- b) Installation error
- c) System Error
- d) Image Loss, Deletion, and Restoration
- e) Image Save Error
- f) Image Information Error
- g) Image Transmission and Reception
- h) Header Verification
- i) Security
- j) Image Acquisition Test
- k) Search Function
- l) Application Function (ELUI S/W)
- m) Resolution
For Ceiling, Suspended, X-ray Tube Support, Detector Stand, Floating top table
- a) Moving distance

The bench test results show that the device is safe and essential performance effectiveness.

Clinical testing

: Clinical testing is not performed for the subject device as the detectors were already 510(k) cleared and the imaging software (Elui) is the same as the predicate device. There were no significant changes.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.