QXLINK by VIEWORKS CO., LTD. | FDA 510(k) Summary

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

AI/ML Overview

This is a 510(k) clearance letter for the QXLink PACS device. As such, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the QXLink device itself.

Therefore, the requested information about acceptance criteria and a study proving the device meets them is not available in the provided document. This document confirms the regulatory clearance based on substantial equivalence, but it does not contain the technical performance study details you're asking for.

Here's why and what can be inferred:

Acceptance Criteria and Reported Device Performance: Not provided in this regulatory letter. Substantial equivalence typically means the new device performs at least as well as the predicate device, but specific quantitative metrics are not detailed here.
Sample size, data provenance, ground truth, adjudication, MRMC, standalone, training set details: These are all elements of a detailed performance study, which would be contained in a separate submission report to the FDA, not in the clearance letter itself.

To obtain the information you're looking for, you would generally need to refer to the original 510(k) submission documentation, which is often much more extensive than the clearance letter.

Summary

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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

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Indications for Use

510(k) Number (if known): K132302

Device Name: Picture archiving and communication system (PACS)/ QXLink

Indications for Use:

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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Regulation Number and Section

§ 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).