(85 days)
No
The document describes a standard digital radiography system with image processing features, but there is no mention of AI or ML technology.
No
The device is described as an imaging system for digital image capture in radiographic examinations, used for diagnosis and not for treating or curing a disease or condition.
Yes
The device is described as "intended for digital image capture use in general radiographic examinations" and the clinical testing section states that human images "were reviewed by a Board Certified Radiologist and found to be of good diagnostic quality." This indicates its use in diagnosing medical conditions based on captured images.
No
The device description explicitly states it is an "integrated flat panel digital detector (FPD)" system and is compatible with specific digital x-ray receptor panels, which are hardware components. While it includes acquisition and processing software, it is not solely software.
Based on the provided text, the Radlink GPS device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's for "digital image capture use in general radiographic examinations." This involves capturing images of the human body using X-rays.
- Device Description: The description details a Digital Radiography (DR) system that replaces conventional film for radiographic examinations. It involves a flat panel digital detector and software for image processing and display.
- Nature of IVDs: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The Radlink GPS system is an imaging device used for diagnostic purposes, but it operates by capturing images of the internal structures of the body using X-rays, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
MOB, MQB
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-Ray
Anatomical Site
pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
- Non-clinical testing: Program testing and calibration using gray-scale wedge and a line resolution phantom demonstrated 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.
- 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.
- Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K120020, K122865, K110849, K140551
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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.
(5) INDICATIONS FOR USE
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.
(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 panel | |
| digital imaging system is intended for use | ||
| in generating radiographic images of | ||
| human anatomy. This device is intended | ||
| to replace film/screen systems in all | ||
| general purpose diagnostic procedures. | ||
| This device is not intended for | ||
| mammography applications. This device | ||
| is intended for use by qualified medical | ||
| personnel and is contraindicated when, | ||
| in the judgment of the physician, | ||
| procedures would be contrary to the best | ||
| interest of the patient. | 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. | ||
| Compatible | ||
| Digital 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.