QXLink

K161113 · Vieworks Co., Ltd. · LLZ · Aug 5, 2016 · Radiology

Device Facts

• Record ID: K161113
• Device Name: QXLink
• Applicant: Vieworks Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 5, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

QXLink is a Picture Archiving and Communication System (PACS) software; facilitates acceptance, transfer, display, storage, and digital processing of medical images. Inputs include images from modalities like CR, CT, and MR. Software performs image manipulation, enhancement, compression, and quantification. Used in clinical environments by healthcare professionals to manage diagnostic imaging workflows. Output consists of processed and displayed medical images for clinical review and decision-making. System supports diagnostic efficiency by enabling centralized image management and viewing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software-based PACS; functions include image manipulation, enhancement, compression, and quantification. Compatible with standard imaging modalities (CR, CT, MR). Connectivity via standard medical imaging protocols. Not intended for mammography.

Indications for Use

Indicated for use in clinical settings for the acceptance, transfer, display, storage, and digital processing of medical images acquired from modalities including CR, CT, and MR. Not indicated for mammography.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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

Auqust 5, 2016

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Suite 417 IRVINE CA 92620

Re: K161113

Trade/Device Name: QXLink Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 5, 2016 Received: July 13, 2016

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 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. 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) K161113

Device Name QXLink

## Indications for Use (Describe)

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 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.

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

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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