Radlink GPS is intended for digital image capture use in general radiographic examinations, whenever conventional screen-film systems may be used. Radlink GPS allows imaging of the pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities. The digital images are transmitted from the panel or from a connection to PACS via computer networks or from a video input port to a personal computer (PC) where they may be displayed, processed, altered, overlaid with templates, compressed for archiving or transmission via computer networks to other medical facility sites. Not for mammography.

Device Description

The Radlink GPS system represents the straightforward integration of digital x-ray receptor panels with their own FDA 510(k) clearance and our acquisition software that has been previously cleared by the FDA for use with our Radlink CR-Pro Solid State X-ray Imager (K052938) and Radlink LaserPro-16 (K020243). The Radlink GPS is compatible with the following digital x-ray receptor panels:

. Vieworks VIVIX-S (K120020) and VIVIX-S Wireless (K122865)
. Trixell Artpix Mobile EZ2GO with portable PIXIUM 3543EZ (K110849)
-Perkin Elmer XRpad 4336 MED (K140551)
Radlink GPS is a Digital Radiography (DR) system, featuring an integrated flat panel digital detector (FPD). Radlink GPS is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operations of the Radlink CR Pro acquisition software and PACS were not changed. The digital copies are transmitted to an internal personal computer (PC) where they may be displayed, processed for archiving or transmission via computer networks to other medical facility sites. Images can be rotated, flipped, coomed, window level, overlaid and annotated (markers, text, freestyle, line distance measurements, angles). Digital images may be received via the flat panel digital detector (FPD), from a connection to PACS via computer networks or from a video input port.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Radlink GPS device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets for performance metrics (e.g., sensitivity, specificity, image quality scores). Instead, the "acceptance criteria" appear to be implicit in demonstrating that the device is "as safe and effective as products currently legally for sale in the USA" and "substantially equivalent to predicate devices."

The reported device performance primarily focuses on functionality, safety, and diagnostic quality rather than specific quantitative performance metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence/Compatibility	Radlink GPS system represents the straightforward integration of digital x-ray receptor panels with existing FDA-cleared acquisition software. It is functionally equal to the predicate device and Radlink CR-Pro product (K052938).
Image Acquisition (Digital Panels)	Proper acquisition of digital x-ray images was verified with each of the three available digital panels (Vieworks VIVIX-S, Trixell Artpix Mobile EZ2GO, Perkin Elmer XRpad 4336 MED). All panels have already been cleared by FDA.
Image Quality (Diagnostic)	Human images were obtained from each of the panels. They were reviewed by a Board Certified Radiologist and found to be of good diagnostic quality.
Conformance to Specifications (Calibration/Resolution)	Program testing and calibration using gray-scale wedge and a line resolution phantom and has demonstrated the Radlink GPS conformance to its defined specifications.
Software Validation & Risk Analysis	Software validation and risk analysis was performed. The templating features software has been validated.
DICOM Compatibility	DICOM compatibility has been verified. (Also listed as "YES" in the Substantial Equivalence Table)
Electrical Safety & EMC	All panels have been tested to meet the requirements of IEC 60601-1 (Medical Device Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
Substantial Equivalence (Features)	Detailed comparison tables (Table 1 & 2) show that Radlink GPS software features are identical to or comparable with previous Radlink software (CR-Pro) and the predicate device (dicomPACS DX-R), with minor workflow changes and the addition of templating features. Compatible digital panels are listed.
Safety and Effectiveness "as legally for sale in the USA"	Concluded based on non-clinical testing, software comparison, and the fact that all proposed compatible panels have undergone successful FDA review, that it is "as safe and effective as products currently legally for sale in the USA."
Intended Use (General Radiographic Examinations)	The device's indications for use are consistent with conventional screen-film systems for general radiographic examinations of pelvis, knee, skull, chest, shoulder, spine, abdomen, and extremities. Not for mammography. This is consistent with the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document states that "Human images were obtained from each of the panels." It does not specify the exact number of human images or cases used for this review.
Data Provenance: Not explicitly stated. Given the context of seeking FDA clearance in the USA, it's likely the images were acquired in a medical setting, possibly in the USA, but no specific country or retrospective/prospective nature is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: "a Board Certified Radiologist." (Singular)
Qualifications of Experts: "Board Certified Radiologist." No specific number of years of experience is provided.

4. Adjudication Method for the Test Set

Adjudication Method: "reviewed by a Board Certified Radiologist." There is no mention of multiple readers or an adjudication process (e.g., 2+1, 3+1). The assessment appears to be a single-reader evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence primarily through functional comparison, technical performance verification, and a limited clinical review by a single radiologist. There is no mention of comparing human readers with and without AI assistance. The device itself is an image acquisition and processing system, not an AI diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: The Radlink GPS is a digital radiography system, not an AI algorithm in the context typically discussed for standalone performance (e.g., detecting disease). Its "performance" is inherently linked to image acquisition and display. The "algorithm" here refers to the acquisition and processing software, and its standalone performance is tested through aspects like "conformance to its defined specifications" using phantoms, software validation, and DICOM compatibility. While not referred to as "standalone AI performance," the non-clinical testing and software validation serve a similar function for the core components of the system.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the diagnostic quality assessment was based on expert consensus (from a single Board Certified Radiologist) who evaluated the human images and found them to be of "good diagnostic quality." For other aspects like image acquisition and technical specifications, the ground truth was based on physical measurements (e.g., gray-scale wedge, line resolution phantom) against predefined technical standards.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable in the context of this submission. The Radlink GPS is described as an integration of existing cleared components (digital panels and acquisition software that was previously cleared). It is not an AI/machine learning model that undergoes a distinct "training phase" on a dataset in the way a diagnostic algorithm would. The software was previously cleared (K052938, K020243), implying its development and validation occurred prior to this submission.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As mentioned above, this is an integration of pre-cleared components, not a new AI algorithm requiring a dedicated training set and associated ground truth establishment for that training. The development and validation of the constituent software and hardware components would have involved their own respective "ground truths" at the time of their original clearance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2014

Radlink, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K142718

Trade/Device Name: Radlink GPS Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: November 14, 2014 Received: November 21, 2014

Dear Mr. Kamm:

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 (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. 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.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert A. Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K142718

Device Name Radlink GPS

Indications for Use (Describe)

Radlink GPS is intended for digital image capture use in general radiographic examinations, whenever conventional screen-film systems may be used. Radlink GPS allows imaging of the pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities. The digital images are transmitted from the panel or from a comection to PACS via computer networks or from a video input port to a personal computer (PC) where they may be displayed, processed, altered, overlaid with templates, compressed for archiving or transmission via computer networks to other medical facility sites. Not for mammography.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 Druq 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."

{3}------------------------------------------------

Attachment 2– 510(k) Summary

{4}------------------------------------------------

Per Title CFR 807.92, the following is the 510(k) Summary for the DR system manufactured and marketed by Radlink Inc. under the trade name Radlink GPS: (1) SUBMITTER Radlink, Inc. 815 N Nash st El Segundo, CA, 90245 Phone: 310 643 6900 Fax: 310 364 3150 Establishment Registration Number: 3005560996 Prepared by: Brian Kordich, Quality Manager Date Prepared: November 14, 2014

(2) DEVICE NAME TRADE NAME: Radlink GPS COMMON NAME: Digital X-Ray Receptor Panel CLASSIFICATION NAME: Stationary X-ray system (Class 2 Device) PRODUCT CODE: MQB. Regulation 892.1680

(3) PREDICATE DEVICE: K141440, dicomPACS DX-R, O&R

(4) DEVICE DESCRIPTION

. Vieworks VIVIX-S (K120020) and VIVIX-S Wireless (K122865)
. Trixell Artpix Mobile EZ2GO with portable PIXIUM 3543EZ (K110849)
-Perkin Elmer XRpad 4336 MED (K140551)

Radlink GPS is a Digital Radiography (DR) system, featuring an integrated flat panel digital detector (FPD). Radlink GPS is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operations of the Radlink CR Pro acquisition software and PACS were not changed. The digital copies are transmitted to an internal personal computer (PC) where they may be displayed, processed for archiving or transmission via computer networks to other medical facility sites. Images can be rotated, flipped, coomed, window level, overlaid and annotated (markers, text, freestyle, line distance measurements, angles). Digital images may be received via the flat panel digital detector (FPD), from a connection to PACS via computer networks or from a video input port.

(5) INDICATIONS FOR USE

(6) SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE

{5}------------------------------------------------

The Radlink GPS is the functional equal to the above named predicate device AND our Radlink CR-Pro product, K052938 and it adds compatibility with 510(k) cleared digital panels which came out after our original submission. The Radlink Digital Radiography System uses the following cleared digital panels: (Supplied unmodified):

Vieworks VIVIX-S (K120020) and VIVIX-S Wireless (K122865) -
Trixell Artpix Mobile EZ2GO with portable PIXIUM 3543EZ (K110849) -
-Perkin Elmer XRpad 4336 MED (K140551)

The Radlink digital radiography system uses the Radlink software which controls image acquisition, processing, storage, transfer, display, and measurement functions that were previously certified with both the Radlink CR-Pro (FDA 510(k): K052938) and the Radlink LaserPro (FDA 510(k): K020243) products.

Features/Company	Radlink 2	Radlink 2
Product Name	CR-Pro	GPS
FDA 510(k) #	K052938	-
Patient Information (Add/Modify/Delete)	Yes	Yes
Fax Report	Yes	Yes
Print DICOM Image	Yes	Yes
Image Rotate & Flip	Yes	Yes
Black/White Inversion	Yes	Yes
Multiple Image Display	Yes	Yes
DICOM Send/Receive/Echo	Yes	Yes
DICOM Query User/Provider	Yes	Yes
DICOM Retrieve User/Provider	Yes	Yes
DICOM Print	Yes	Yes
JPEG Compression lossy/lossless	Yes	Yes
JPEG Compression	Yes	Yes
Wavelet Compression	Yes	Yes
Industry Standard Digital Communication Support	Yes	Yes
Color Images	No	No
Cine Loop Viewing	No	No
DICOM Removable Media Support	Yes	Yes
Measurement Tools	Yes	Yes
Communication Protocols	Yes 1	Yes 1

Table 1: Substantial Equivalence Table: Software: Comparison to our previous software.

1 ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring.

2 The LaserPro-16 and CR-Pro are previously cleared software products of Radlink, Inc. These are cited as a Predicate Device because the application software utilized in the Radlink DR System is the exact same software used in the LaserPro-16 and CR-Pro units with very minor work-flow changes.

{6}------------------------------------------------

Item	K141440, dicomPACS DX-R, O&R	Radlink GPS
Indications for Use	The dicomPACS DX-R with flat paneldigital imaging system is intended for usein generating radiographic images ofhuman anatomy. This device is intendedto replace film/screen systems in allgeneral purpose diagnostic procedures.This device is not intended formammography applications. This deviceis intended for use by qualified medicalpersonnel and is contraindicated when,in the judgment of the physician,procedures would be contrary to the bestinterest of the patient.	Radlink GPS is intended for digital image captureuse in general radiographic examinations, wheneverconventional screen-film systems may be used.Radlink GPS allows imaging of the pelvis, knee, skull,chest, shoulder, spine, abdomen and extremities.The digital images are transmitted from the panel orfrom a connection to PACS via computer networksor from a video input port to a personal computer(PC) where they may be displayed, processed,altered, overlaid with templates, compressed forarchiving or transmission via computer networks toother medical facility sites. Not for mammography.
CompatibleDigital Panels	Toshiba FDX4343R,Toshiba FDX3543RP,Konica Minolta AeroDR P-11 (1417HQ).Pixium Portable 2430 EZ (wireless)Pixium Portable 3543 EZ (wireless)Perkin Elmer 4336 XRpad (wireless) :	Vieworks VIVIX-S (K120020)Vieworks VIVIX-S Wireless (K122865)PIXIUM 3543EZ (K110849) (wireless)Perkin Elmer XRpad 4336 MED (K140551) (wireless)
DICOM	YES	YES
Templating	NO	YES

Table 2: Substantial Equivalence Table: Digital Panel Upgrade Kit

(6) Summary of Non-clinical testing. Program testing and calibration using gray-scale wedge and a line resolution phantom and has demonstrated the Radlink GPS conformance to its defined specifications. Proper acquisition of digital x-ray images was verified with each of the three available digital panels. All panels have been tested to meet the requirements of IEC 60601-1 (Medical Device Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). All panels have already been cleared by FDA. DICOM compatibility has been verified. Software validation and risk analysis was performed. The templating features software has been validated.
(7) Summary of Clinical testing. Human images were obtained from each of the panels. They were reviewed by a Board Certified Radiologist and found to be of good diagnostic quality. Physician Evaluation of the Templating Software was performed successfully.
(8) Conclusion: Based on the non-clinical testing, and a comparison of software features (Tables above) and the fact that all three proposed compatible panels have already undergone successful FDA review, we conclude that the Radlink GPS product is as safe and effective as products currently legally for sale in the USA and is therefore substantially equivalent to predicate devices.

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.