K Number
K132302
Device Name
QXLINK
Manufacturer
Date Cleared
2013-09-12

(50 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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. Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
Device Description
Picture archiving and communication system (PACS)/ QXLink
More Information

Not Found

Not Found

No
The summary mentions image processing and manipulation but does not contain any terms or descriptions indicative of AI or ML technology.

No
The device is a Picture Archiving and Communication System (PACS) that processes and stores medical images, but it does not perform any therapeutic functions.

No
The text indicates the device is primarily for image handling (acceptance, transfer, display, storage, processing, manipulation), which are functions of a Picture Archiving and Communication System (PACS) rather than diagnostic interpretation. It does not mention providing a diagnosis or diagnostic aid.

Yes

The device description explicitly states "Picture archiving and communication system (PACS)/ QXLink" and the intended use describes software functions for image handling and processing, without mentioning any associated hardware components being part of the device itself.

Based on the provided information, the QXLink device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device deals with the acceptance, transfer, display, storage, and digital processing of medical images. IVDs are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: It is described as a Picture Archiving and Communication System (PACS). PACS systems are designed for managing and viewing medical images, not for analyzing biological samples.
  • Input: The input is medical images from imaging devices (CR, CT, MR, etc.), not biological specimens.

Therefore, the QXLink falls under the category of medical imaging devices or systems, not In Vitro Diagnostics.

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 may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. 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

LLZ

Device Description

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.

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

Prescription Use

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)

Not Found

Reference Device(s)

Not Found

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).

0

Image /page/0/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central graphic consists of three stylized, overlapping shapes that resemble a bird or a stylized human figure, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Goll Silver Spring, MI) 20993-0002

September 12, 2013

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc. 1515 E. Katella Avenue, Unit 2115 ANAHEIM CA 92805

Re: K132302

Trade/Device Name: QXLink Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ. Dated: July 17, 2013 Received: July 24, 2013

Dear Ms. Chung:

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 10 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.

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Page 2 - Ms. Chung

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.hum.

Sincerely yours,

Smh7)

for

Janine M. Morris 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): K132302

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 may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. 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 X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

fmh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

210(k) == K132302

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