(237 days)
No
The description focuses on image processing, measurement tools, and previously cleared technologies, with no mention of AI or ML.
No.
Explanation: This software is an image processing tool intended to assist with measurements and annotations on radiological images for hip procedures; it does not directly treat or diagnose a disease or condition.
No
The device is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position and to assist orthopedic surgeons in positioning hip, knee, and trauma components. It is not for primary image interpretation and clinical judgment is required, indicating it is an assistive tool rather than a diagnostic one.
Yes
The device description explicitly states it is "image processing software" and details its compatibility with a standard operating system and minimal hardware requirements, indicating it is a software application running on general-purpose computing hardware, not a dedicated hardware device.
Based on the provided information, the Radlink GPS Pro Imaging device 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.
- Radlink GPS Pro Imaging Function: The description clearly states that Radlink GPS Pro Imaging is an image-processing software used to assist in hip procedures by measuring anatomical structures from radiological images. It works with images obtained from modalities like C-Arm, X-Ray, and CT.
- No Biological Samples: The device does not involve the analysis of any biological samples taken from the patient. Its function is solely based on processing and analyzing medical images.
Therefore, while it is a medical device used in a clinical setting, its function falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Product codes
LLZ
Device Description
The Radlink® GPS Pro Imaging is an image processing software designed to assist orthopedic surgeons in positioning hip, knee, and trauma components. The software leverages advanced geographic measurement and stitching technologies, which have been previously FDA cleared, ensuring precise and reliable image handling. These foundational technologies continue to be the primary features of software.
Additionally, Radlink GPS Pro Imaging software supports complete image acquisition and DICOM transmission capabilities, facilitating seamless integration with existing hospital systems. It is compatible with Windows operating system, and requires minimal hardware specifications, making it a versatile solution for different clinical setups.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
C-Arm, X-Ray, CT
Anatomical Site
Hip (acetabulum)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeons. Not Found for care setting.
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)
Comprehensive cybersecurity testing and software verification activities were conducted in accordance with applicable FDA guidance and recognized standards. These assessments confirm that the device's software meets the required performance, safety, and security criteria.
The verification and validation testing, including software performance, segmentation accuracy, usability evaluation, and cybersecurity assessment, confirms that the subject device performs as safely and effectively as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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March 18, 2025
Radlink, Inc. % Victoria Nadershahi Director of Regulatory Affairs 2101 E El Segundo Blvd., Suite 104 EL SEGUNDO, CA 90245
Re: K242161
Trade/Device Name: Radlink GPS Pro Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: February 10, 2025 Received: February 10, 2025
Dear Victoria Nadershahi:
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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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
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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
3
Indications for Use
510(k) Number (if known) K242161
Device Name Radlink GPS Pro Imaging
Indications for Use (Describe)
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
| 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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K242161 510(k) Summary
| Applicant Name: | Radlink, Inc. |
|---|---|
| 2101 E. El Segundo Blvd., Suite 104 | |
| El Segundo, CA 90245 |
| Applicant Contact: | Victoria Nadershahi |
|---|---|
| Email: | vnadershahi@radlink.com |
| Phone: | (310)717-5822 |
| Date Prepared: | March 13, 2025 |
Device Information:
- . Device Trade Name: Radlink GPS Pro Imaging
- . Common Name: Medical image management and processing system
- Regulation Number: 892.2050 ●
- Device Class: ll
- LLZ ● Product Code:
Predicate & Reference Devices:
- Primary Predicate Device: CUPTIMIZE™ Advanced (K231503), Regulation Number: 892.2050, Product ● Code: LLZ
- . Secondary Predicate Device: Radlink® GPS (K142718), Regulation Number: 892.1680, Product Code: LLZ/MQB
- Reference Device: K233761
Indications for Use:
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Device Description:
The Radlink® GPS Pro Imaging is an image processing software designed to assist orthopedic surgeons in positioning hip, knee, and trauma components. The software leverages advanced geographic measurement and
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Image /page/5/Picture/0 description: The image shows the logo for Radlink. The logo consists of three yellow squares followed by the word "RADLINK" in blue. The squares are arranged horizontally, with each square slightly offset from the others.
stitching technologies, which have been previously FDA cleared, ensuring precise and reliable image handling. These foundational technologies continue to be the primary features of software.
Additionally, Radlink GPS Pro Imaging software supports complete image acquisition and DICOM transmission capabilities, facilitating seamless integration with existing hospital systems. It is compatible with Windows operating system, and requires minimal hardware specifications, making it a versatile solution for different clinical setups.
Substantial Equivalence:
Table 1: Predicate Comparison Table
| Feature | Subject Device | Primary Predicate
Device | Secondary Predicate
Device |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Radlink, Inc. | DePuy Orthopedics,
Inc. | Radlink, Inc. |
| Device Name | Radlink GPS Pro
Imaging | Cuptimize™ Advanced | Radlink GPS |
| FDA 510(k) # | K242161 | K231503 | K142718 |
| Regulatory Number | 892.2050 | 892.2050 | 892.1680 |
| Product Code | LLZ | LLZ | LLZ/MQB |
| Device Class | II | II | II |
| Intended Use | Radlink GPS Pro
Imaging is an image-
processing software
intended to assist in hip
procedures by
measuring the
acetabulum's position
relative to local bone
structures identified from
radiological images.
The device allows for
overlaying digital
annotations on
radiological images and
includes tools for
performing
measurements using the
images and digital
annotations. Clinical
judgment and experience
are required to properly
use the software. The
software is not for
primary image
interpretation. The
software is not for use on
mobile phones. | Preoperative
templating for
orthopedic procedures
and intraoperative data
for total hip
arthroplasties (THA) to
provide the following:
• Accurate digital
templating by allowing
'real time' templating
in the OR using direct
measurement and
template rescaling.
• Intraoperative
surgical guidance,
including offset, leg
length,
anteversion and
abduction angle data. | Preoperative
templating for
orthopedic procedures
to provide the
following:
• Accurate digital
templating by allowing
'real time' templating
in the OR using direct
measurement and
template rescaling.
(OrthoPlan®)
• Intraoperative
surgical guidance,
including offset, leg
length,
anteversion and
abduction angle data. |
| PACS Image
Compatibility | C-Arm, X-Ray, CT | C-Arm, X-Ray | C-Arm, X-Ray |
| Operating System | Windows | Windows, iOS | Windows |
| Cybersecurity
Enhancements | Yes | Stated, but details
unavailable | Limited |
510(k) Summary
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Image /page/6/Picture/0 description: The image shows the word "RADLINK" in a sans-serif font. The word is teal in color. To the left of the word are three yellow squares in a horizontal line. The squares are slightly offset from each other.
Performance Data
Comprehensive cybersecurity testing and software verification activities were conducted in accordance with applicable FDA guidance and recognized standards. These assessments confirm that the device's software meets the required performance, safety, and security criteria.
Conclusion:
The Radlink Pro Imaging Software has been demonstrated to be substantially equivalent to the predicate devices Cuptimize™ Advanced (K231503) and Radlink GPS (K142718). The subject device shares the same intended use and fundamental technology, while incorporating enhancements that do not raise new or different questions of safety and effectiveness.
The verification and validation testing, including software performance, segmentation accuracy, usability evaluation, and cybersecurity assessment, confirms that the subject device performs as safely and effectively as the predicate devices.