JLK-AILink is a software that receives digital images and data from various sources (i.e., CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and analyzed data with optional modules can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals including but not limited to physicians and medical technicians. The device is not intended for mammography.

Device Description

JLK-AILink is a software designed to streamline the management, visualization, and communication of medical imaging data within clinical workflows. It facilitates bidirection with hospital PACS systems or imaging equipment such as MR, CT, or X-ray scanners, enabling the communication of DICOM images. This functionality ensures seamless integration with existing hospital IT infrastructure while adhering to DICOM communication standards.

The software includes a DICOM viewer that offers tools for image manipulation and annotation, such as zoom, magnify, contrast adjustment, cobb angle measurement, and annotation tools, making it an efficient and userfriendly interface for medical professionals. The modular architecture allows healthcare institutions to integrate optional analysis solutions with DICOM communication to expand its image analysis capabilities as needed.

JLK-AlLink also supports mobile access, enabling clinicians to view images, interact with annotations, and receive critical alerts remotely. With a focus on interoperability, the software ensures compatibility not only with PACS systems but also with containerized environments, allowing for secure and data management.

This combination of DICOM functionalities, modular integration, and mobile accessibility makes ILK-AILink a clinical tool for enhancing clinical workflows and improving the efficiency of medical imaging data usage in diverse healthcare settings.

AI/ML Overview

The provided FDA 510(k) clearance letter for JLK-AILink (K250348) primarily focuses on establishing substantial equivalence to a predicate device (STARPACS™ K031013) for a general medical image management and processing system. The documentation explicitly states that "JLK-AILink is a software that receives digital images and data from various sources... Images and analyzed data with optional modules can be stored, communicated, processed, and displayed..."

However, the provided text does not contain the detailed information required to describe the acceptance criteria and the specific study proving the device meets those criteria for any optional analysis modules. The clearance is for the base platform, which is a medical image management and processing system, not an AI-powered diagnostic or assistive tool with specific performance metrics.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7-8) states:
"JLK-AILink was designed and developed according to the standards required for software development. For software evaluation, software functionality, risk management, cybersecurity, verification, validation, and requirements were addressed. The evaluation was tested according to the verification and validation processes and planning, and the test results support that all system requirements have met their acceptance criteria and are adequate for their intended use."

This statement confirms that the base system functionality (image reception, storage, communication, processing, display, and features like zoom, magnify, contrast adjustment, Cobb angle measurement, annotation tools) was verified and validated against its design requirements and acceptance criteria, but it does not specify what those criteria were in a quantitative sense, nor does it detail a performance study as one would expect for an AI/ML diagnostic or assistive device that provides analytical outputs (e.g., disease detection, segmentation, quantitative measurements relevant to a clinical endpoint).

Therefore, based solely on the provided text, the following information cannot be extracted:

A table of acceptance criteria and reported device performance for an AI module: The document describes the system as a general image management and processing system. While it mentions "optional modules" that can expand its "image analysis capabilities," the clearance itself (K250348) pertains to the core platform, not specific AI analysis functionalities that would require detailed performance metrics.
Sample size for the test set: Not mentioned.
Data provenance for the test set: Not mentioned.
Number of experts used to establish ground truth: Not mentioned, as ground truth for specific AI analysis outputs is not addressed.
Qualifications of experts: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: Not mentioned. The focus is on functionality and equivalence to a predicate PACS system, not comparative clinical performance for an AI-assisted workflow.
Effect size of human reader improvement with AI assistance: Not applicable based on the scope of clearance described.
Standalone (algorithm only) performance: Not mentioned, as no specific AI algorithm's performance is described.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned.
How ground truth for the training set was established: Not mentioned.

In summary: The provided 510(k) clearance letter for JLK-AILink pertains to a general medical image management and processing system (PACS-like functionality), falling under Regulation Number 892.2050 and Product Code LLZ. This product code typically covers systems that handle, display, and process medical images, but does not inherently imply specific AI diagnostic or analytical capabilities that would necessitate the detailed performance study information requested. The "optional modules" are noted, but their specific functionalities and performance (if they are AI-powered analytics) are not covered in this general clearance document.

To answer your questions for an AI-enabled device with specific analytical functions, one would typically need a 510(k) summary that details the performance of those specific AI modules, rather than just the general image management system.

Summary

FDA 510(k) Clearance Letter - JLK-AILink

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

JLK, Inc.
℅ Dave Yungvirt
CEO
Third Party Review Group, LLC
25 Independence Blvd
Warren, New Jersey 07059

Re: K250348
Trade/Device Name: JLK-AILink
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: February 6, 2025
Received: February 6, 2025

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.

February 25, 2025

Page 2

JLK, Inc.
℅ Dave Yungvirt
CEO
Third Party Review Group, LLC
25 Independence Blvd
Warren, New Jersey 07059

February 25, 2025

Dear Dave Yungvirt:

K250348 - Dave Yungvirt 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-

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 3

K250348 - Dave Yungvirt 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,

Jessica Lamb, Ph.D.
Assistant Director
Imaging Software Team
DHT 8B: 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

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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)
K250348

Device Name
JLK-AILink

Indications for Use (Describe)
JLK-AILink is a software that receives digital images and data from various sources (i.e., CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and analyzed data with optional modules can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals including but not limited to physicians and medical technicians. 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."

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

510(k) Number (if known)
K250348

Device Name
JLK-AILink

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.

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

Page 5

510(k) Summary JLK, Inc.
11F, 5, Teheran-ro 33 gil, Gangnam-gu,
Seoul, Republic of Korea
+82)70-4651-4051

February 22, 2025

510(k) Summary

1. Contact Details (21 CFR 807.92(a)(1))

Applicant Name: JLK, Inc.
Applicant Address: JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul n/a 06141 Korea, South
Applicant Contact Telephone: (+82)1038507933
Applicant Contact: Dr. Dongmin Kim
Applicant Contact Email: dmkim@jlkgroup.com
Correspondent Name: JLK, Inc.
Correspondent Address: JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul n/a 06141 Korea, South
Correspondent Contact Telephone: (+82)1027905959
Correspondent Contact: Ms. Sunyoung Jang
Correspondent Contact Email: syjang@jlkgroup.com

2. Device Name (21 CFR 807.92(a)(2))

Device Trade Name	JLK-AILink
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Regulation Number	892.2050
Product Code(s)	LLZ

3. Legally Marketed Predicate Devices (21 CFR 807.92(a)(3))

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K031013	STARPACS™	LLZ

4. Device Description Summary (21 CFR 807.92(a)(4))

JLK-AILink is a software designed to streamline the management, visualization, and communication of medical imaging data within clinical workflows. It facilitates bidirectional communication with hospital PACS systems or imaging equipment such as MR, CT, or X-ray scanners, enabling the communication of DICOM images. This functionality ensures seamless integration with existing hospital IT infrastructure while adhering to DICOM communication standards.

The software includes a DICOM viewer that offers tools for image manipulation and annotation, such as zoom, magnify, contrast adjustment, cobb angle measurement, and annotation tools, making it an efficient and user-friendly interface for medical professionals. The modular architecture allows healthcare institutions to integrate optional analysis solutions with DICOM communication to expand its image analysis capabilities as needed.

JLK-AILink also supports mobile access, enabling clinicians to view images, interact with annotations, and receive critical alerts remotely. With a focus on interoperability, the software ensures compatibility not only with PACS systems but also with containerized environments, allowing for secure and data management.

This combination of DICOM functionalities, modular integration, and mobile accessibility makes JLK-AILink a clinical tool for enhancing clinical workflows and improving the efficiency of medical imaging data usage in diverse healthcare settings.

Page - 1
K250348

Page 6

11F, 5, Teheran-ro 33 gil, Gangnam-gu,
Seoul, Republic of Korea
+82)70-4651-4051

February 22, 2025

K250348

510(k) Summary

1. Contact Details (21 CFR 807.92(a)(1))

Applicant Name: JLK, Inc.
Applicant Address: JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul n/a 06141 Korea, South
Applicant Contact Telephone: (+82)1038507933
Applicant Contact: Dr. Dongmin Kim
Applicant Contact Email: dmkim@jlkgroup.com
Correspondent Name: JLK, Inc.
Correspondent Address: JLK Tower, 5, Teheran-ro 33-gil Gangnam-gu Seoul n/a 06141 Korea, South
Correspondent Contact Telephone: (+82)1027905959
Correspondent Contact: Ms. Sunyoung Jang
Correspondent Contact Email: syjang@jlkgroup.com

2. Device Name (21 CFR 807.92(a)(2))

Device Trade Name	JLK-AILink
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Regulation Number	892.2050
Product Code(s)	LLZ

3. Legally Marketed Predicate Devices (21 CFR 807.92(a)(3))

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K031013	STARPACS™	LLZ

4. Device Description Summary (21 CFR 807.92(a)(4))

JLK-AILink is a software designed to streamline the management, visualization, and communication of medical imaging data within clinical workflows. It facilitates bidirectional communication with hospital PACS systems or imaging equipment such as MR, CT, or X-ray scanners, enabling the communication of DICOM images. This functionality ensures seamless integration with existing hospital IT infrastructure while adhering to DICOM communication standards.

The software includes a DICOM viewer that offers tools for image manipulation and annotation, such as zoom, magnify, contrast adjustment, cobb angle measurement, and annotation tools, making it an efficient and user-friendly interface for medical professionals. The modular architecture allows healthcare institutions to integrate optional analysis solutions with DICOM communication to expand its image analysis capabilities as needed.

510(k) Summary
JLK, Inc.
Page - 1

Page 7

510(k) Summary JLK, Inc.
11F, 5, Teheran-ro 33 gil, Gangnam-gu,
Seoul, Republic of Korea
+82)70-4651-4051

5. Intended Use/Indications for Use (21 CFR 807.92(a)(5))

6. Indications for Use Comparison (21 CFR 807.92(a)(5))

Both JLK-AILink and STARPACS™ are designed as software applications for managing, processing, storing, and displaying medical images and associated data. These systems support healthcare professionals in clinical environments by facilitating the interpretation and management of digital images from various imaging modalities, such as CT, MRI, ultrasound, and radiographic devices. Neither device is intended to provide a clinical diagnosis independently but serves as a supportive tool for trained professionals.

7. Technological Comparison (21 CFR 807.92(a)(6))

Both JLK-AILink and STARPACS™ are software-based systems designed for medical image management and processing. These systems receive digital images and data from various imaging modalities, including CT, MRI, ultrasound, and radiographic devices. The images and data are stored, communicated, processed, and displayed within the system or across distributed computer networks to assist healthcare professionals in clinical workflows.

In summary, JLK-AILink and STARPACS™ share technological characteristics and meet equivalent safety and performance standards, ensuring their substantial equivalence for regulatory purposes.

8. Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))

JLK-AILink was designed and developed according to the standards required for software development. For software evaluation, software functionality, risk management, cybersecurity, verification, validation, and requirements were addressed. The evaluation was tested according to the verification and validation processes and planning, and the test results support that all system requirements have met their acceptance criteria and are adequate for their intended use.

JLK, Inc. conducted extensive software verification and validation test of the JLK-AILink. This v&v testing demonstrated that the JLK-AILink system accurately represents key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. The documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Content of Premarket Submissions for Device Software Functions," June 14, 2023.

In conclusion, JLK-AILink, is substantially equivalent to the legally marketed predicate device, STARPACS™ (K031013).

Page - 2

Page 8

11F, 5, Teheran-ro 33 gil, Gangnam-gu,
Seoul, Republic of Korea
+82)70-4651-4051

5. Intended Use/Indications for Use (21 CFR 807.92(a)(5))

6. Indications for Use Comparison (21 CFR 807.92(a)(5))

7. Technological Comparison (21 CFR 807.92(a)(6))

In summary, JLK-AILink and STARPACS™ share technological characteristics and meet equivalent safety and performance standards, ensuring their substantial equivalence for regulatory purposes.

8. Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))

In conclusion, JLK-AILink, is substantially equivalent to the legally marketed predicate device, STARPACS™ (K031013).

510(k) Summary
JLK, Inc.
Page - 2

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).