(19 days)
Not Found
Unknown
The document mentions "optional analysis solutions" and "image analysis capabilities" which could potentially utilize AI/ML, but the summary itself does not explicitly state that AI/ML is incorporated. The "Mentions AI, DNN, or ML" field is marked "Not Found".
No
The device is a software that manages, displays, and processes medical imaging data, which are functions of a diagnostic imaging system, not a therapeutic device.
No
The device is described as software for managing, visualizing, and communicating medical imaging data. While it offers tools for image manipulation and annotation, there is no mention of it providing a medical diagnosis, aiding in diagnosis, or performing any disease detection or characterization. Its primary function appears to be workflow enhancement for medical imaging data, not diagnostic interpretation itself.
Yes
The device description explicitly states that JLK-AILink is a "software designed to streamline the management, visualization, and communication of medical imaging data." It focuses on software functionalities like DICOM communication, viewing tools, modular architecture for integrating optional analysis solutions, and mobile access. There is no mention of any accompanying hardware component that is part of the device itself. The hardware it interacts with (scanners, PACS, mobile devices) are external sources or platforms.
Based on the provided information, JLK-AILink is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- JLK-AILink's Function: JLK-AILink is a software designed to manage, visualize, and communicate medical imaging data. It receives images from various imaging modalities (CT, MR, X-ray, etc.) and provides tools for viewing, manipulating, and annotating these images.
- No Sample Analysis: The description of JLK-AILink does not mention any analysis of biological samples. Its function is centered around the processing and display of medical images.
Therefore, JLK-AILink falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
JLK-AILink is a software that receives digital images and data from various sources (i.e., CT scanners, ultrasound systems, computed & direct radio devices, secondary capture devices, scanners, maging 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals including but not limited to physicians and medical technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
JLK-AlLink was designed and developed according to the standards required for software development. For software evaluation, software functionality, risk management, 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-AlLink 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
JLK, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
February 25, 2025
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.
1
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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
2
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
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
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Indications for Use
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, ultrasound systems, computed & direct radio devices, secondary capture devices, scanners, maging 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) |
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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
| 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 |
2. Device Name (21 CFR 807.92(a)(2))
3. Legally Marketed Predicate Devices (21 CFR 807.92(a)(3))
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K031013 | STARPACSTM | 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 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.
5
5. Intended Use/Indications for Use (21 CFR 807.92(a)(5))
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.
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-AlLink was designed and developed according to the standards required for software development. For software evaluation, software functionality, risk management, 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-AlLink 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).