eUnity

K161515 · Client Outlook, Inc. · LLZ · Nov 15, 2016 · Radiology

Device Facts

• Record ID: K161515
• Device Name: eUnity
• Applicant: Client Outlook, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 15, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data. eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Device Story

eUnity is a software-based Picture Archiving and Communication System (PACS) component. It functions as a viewer for medical images and clinical reports. Input consists of medical image data; output is a visual display of images and reports on a workstation. Operated by medical professionals in clinical environments. Enables image manipulation (window/level, rotation, measurement, markup). Supports lossy compressed images, requiring user verification of image quality for diagnostic suitability. Facilitates clinical review and decision-making by providing access to diagnostic-quality images.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and verification of software functionality.

Technological Characteristics

Software-only PACS viewer. Operates on standard hardware. Supports standard medical image formats. Includes tools for image manipulation (window/level, rotation, measurement, markup). Compliant with DICOM standards for image transfer and display. No specific hardware materials or energy sources; relies on host workstation and display monitor performance.

Indications for Use

Indicated for medical professionals to transfer, store, display, and measure medical image data and associated clinical reports for diagnostic purposes.

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).

Predicate Devices

• eUnity (K142655)

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

November 15, 2016

Client Outlook Inc. % Ms. Christie Eby Director of Operations and Quality 103 Bauer Place, Suite #3 Waterloo, Ontario, N2L6B5 CANADA

Re: K161515

Trade/Device Name: eUnity Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2016 Received: October 18, 2016

Dear Ms. Eby:

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 O'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

For

Enclosure

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## Indications for Use

510(k) Number (if known) K161515

Device Name eUnity

Indications for Use (Describe)

eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data.

eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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