(12 days)
Not Found
No
The document describes standard PACS functionality for image storage, viewing, and basic manipulation. There is no mention of AI, ML, or advanced analytical capabilities that would typically indicate the use of such technologies.
No
The device is described as a PACS (Picture Archiving and Communication System) software for storing, displaying, and processing medical images. Its functions relate to image management and manipulation, not direct patient therapy or treatment.
No
Explanation: The device is a Picture Archiving and Communication System (PACS) software for storing, viewing, and processing medical images. It does not perform diagnosis itself but supports the diagnostic process by managing images for radiologists and physicians.
Yes
The description explicitly states "QXLink is PACS (Picture Archiving and Communication System) software" and details its functions as software components for image handling and processing, without mentioning any proprietary hardware components included with the device.
Based on the provided information, the QXLink 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.
- QXLink's Function: The description clearly states that QXLink is a PACS (Picture Archiving and Communication System) software that handles medical images acquired from imaging devices like CR, CT, and MR. It focuses on the acceptance, transfer, display, storage, and digital processing of these images.
- No Mention of Biological Samples: There is no mention of QXLink interacting with or analyzing biological samples from the human body. Its input is medical images, not biological specimens.
Therefore, QXLink falls under the category of medical imaging software and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
QXLink is PACS (Picture Archiving and Communication System) software for radiologist and physician doctor. QXLink enables images such as x-ray to be stored electronically and viewed on screens. QXLink conforms to the DICOM standards to allow the sharing of medical information with other digital Imaging system.
Also, QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement or quantification. And images may be acquired from imaging devices such as CR, CT, MR and other devices.
QXLink consists of QXLink Server and QXLink Viewer and the main functions of QXLink are as follows.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, MR and other devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist and physician doctor.
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)
Not Found
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
510(k) Summary
JUL 21 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: May 10, 2009
- Company and Correspondent making the submission:
Name - Vieworks Co., Ltd.
Address - #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-806 South Korea
Telephone - +82-70-7011-6190
Fax - +82-31-737-4954
Contact - Mr. BongGu, Lee
Internet - http://www.vieworks.com
2. Device :
| Trade/proprietary name | : QXLink |
|---|---|
| Common Name | : Picture archiving and communication system(PACS) |
| Classification Name | : Imaging Processing System, Radiological |
3. Predicate Device :
| Manufacturer | : Mediface Co., Ltd. |
|---|---|
| Device | : MEDIFACE PACS |
| 510(k) Number | : K010259(Decision Date - Jan. 29. 2001) |
| Manufacturer | : EMSOMA Co., Ltd. |
| Device | : PetaVision |
| 510(k) Number | : K083555(Decision Date - Dec. 16. 2008) |
- Classifications Names & Cltations :
21CFR 892.2050, LLZ, Imaging Processing System, Radiological, Class2
Vieworks Co., Ltd.
00000017
1
5. Description :
5.1 General
QXLink is PACS (Picture Archiving and Communication System) software for radiologist and physician doctor. QXLink enables images such as x-ray to be stored electronically and viewed on screens. QXLink conforms to the DICOM standards to allow the sharing of medical information with other digital Imaging system.
Also, QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement or quantification. And images may be acquired from imaging devices such as CR, CT, MR and other devices.
QXLink consists of QXLink Server and QXLink Viewer and the main functions of QXLink are as follows.
5.2 Main Function
5.2.1 Image Archive
QXLink Server stores DICOM images that are transmitted in the form of DICOM protocol from each of various modalities. And it saves the information of that image into Database.
5.2.2 Query/Retrieve
QXLink Viewer can search the information of specific DICOM image through DICOM protocol. It queries that information using the several matching attributes (patient name, patient id, sex, study description, study id, accession number, and study date range). It requests QXLink Server to transfer the specific DICOM image:
5.2.3 Image display
QXLink Viewer displays DICOM image on the monitor as if film is read at the film view box. It has several functions to help view images, which are zoom, pan, windowllevel, invert and so on. It can support that a doctor reports and documents the diagnostic conclusion to the Structured Report file (DICOM format). It can also export DICOM images to CD/DVD disk
Vieworks Co., Ltd.
0000018
2
510(k) Submission - QXLink
and print them to DICOM/Paper printer.
-
- Indication for use :
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
- Indication for use :
-
- Comparison with predicate device :
Vieworks Co., Ltd., believes that the Picture archiving and communication system(QXLink) is substantially equivalent to the MEDIFACE PACS of Mediface Co., Ltd. and the PetaVision of EMSOMA Co., Ltd..
- Comparison with predicate device :
-
- Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Vieworks Co., Ltd. concludes that The QXLink is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions :
-
- Vieworks Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- Vieworks Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
3
Image /page/3/Picture/0 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 coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
L.21 2009
Vieworks, Co., Ltd. % Mr. Marc M. Mouser CAS Manager II / Office Coordinator Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K092081
Trade/Device Name: Picture archiving and communication system (PACS)/QXLink Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: LLZ Dated: June 8, 2009 Received: July 9, 2009
Dear Mr. Mouser:
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.
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 of medical
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lucille M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
0920 8 510(k) Number (if known):
Device Name: Picture archiving and communication system (PACS)/ QXLink
Indications for Use:
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Larry M. Khan
(Division Division of Reproductive. Abdominal and Radiological Devic 510(k) Number
Page 1 of 1
00000016