REMOTEYE VIEWER

K141061 · Neologica S.R.L. · LLZ · Aug 1, 2014 · Radiology

Device Facts

• Record ID: K141061
• Device Name: REMOTEYE VIEWER
• Applicant: Neologica S.R.L.
• Product Code: LLZ · Radiology
• Decision Date: Aug 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis. Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

Device Story

RemotEye Viewer is a web-based software application for viewing, manipulating, and interpreting DICOM medical images; inputs include multi-modality DICOM image data retrieved from remote network locations; software enables image visualization, window/level adjustment, zooming, panning, rotation, flipping, cine-playback, and multi-planar reconstruction (MPR); output is displayed on a client machine for interpretation by trained professionals (radiologists, physicians, nurses, technicians); device facilitates clinical diagnosis by providing diagnostic-level image review; software operates on Windows, Mac OS X, and Linux platforms; no DICOM files are permanently stored on client PCs; integrates with external DICOM archives.

Clinical Evidence

Bench testing only. Verification and validation were performed according to internal software development processes and documented specifications to ensure functionality and performance equivalence to the predicate.

Technological Characteristics

Web-based software architecture; multi-platform (Windows, Mac OS X, Linux); DICOM-compliant; supports multi-modality image display, MPR, and standard image manipulation tools (zoom, pan, window/level, measurements, annotations).

Indications for Use

Indicated for trained professionals (radiologists, physicians, nurses, technicians) to view, interpret, and manipulate DICOM-formatted medical multi-modality images 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

• eFilm Workstation (K012211)

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

August 1, 2014

NEOLOGICA S.R.L. MARCO SAMBIN STRADA VILLE, 58 17014 CAIRO MONTENOTTE (SV) ITALY

Re: K141061 Trade/Device Name: RemotEve Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 16, 2014 Received: July 21, 2014

Dear Mr. Sambin:

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.

Smh.f)

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) K141061

Device Name RemotEye Viewer

Indications for Use (Describe)

The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.f)

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Image /page/3/Picture/1 description: The image shows the text "005 Al 510(k) Summary of Safety and Effectiveness". The text is in bold font and is centered on the page. The text is likely the title of a document or report. The number 005 is likely a document number or identifier.

Date Prepared: April 15, 2014 Date of Additional Information: July 16, 2014

Submitter's Name: NeoLogica s.r.l. Submitter's Address: Strada Ville, 58 - 17014 - Cairo Montenotte (SV) - Italy Submitter's Phone Number: [phone] Submitter's E-mail: [e-mail] Submitter's Website: www.neologica.it

Establishment Registration Name: NEOLOGICA S.R.L. Establishment Registration Number: 3005202320

Contact person's Name: Marco Sambin Contact person's Title: Director Contact person's Phone Number: [phone] Contact person's E-mail: [e-mail]

Device Common Name: DICOM-compliant medical image viewer Device Trade Name: RemotEye Viewer Device Classification Name: System, Image Processing, Radiological Device Regulation Description: Picture archiving and communications system Device Regulation Medical Specialty: Radiology Device Review Panel: Radiology Product Code: LLZ Device Regulation Number: 892.2050 Device Class: II Device 510(k) Number: K141061

Predicate Device: eFilm Workstation Predicate Device Original Applicant: eFilm Medical, Inc. - 500 University Ave., Suite 300, Toronto, Ontario Canada M5G 1V7 Predicate Device 510(k) Number: K012211 Predicate Device Classification Name: System, Image Processing, Radiological Predicate Device Regulation Description: Picture archiving and communications system Predicate Device Classification Advisory Committee: Radiology

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Image /page/4/Picture/1 description: The image shows a logo with the word "neologica" in a stylized font. Below the word, there are two smaller words, "Research" and "Development", separated by a curved line. The logo has a modern and clean design, with a focus on the company's name and its areas of expertise.

Predicate Device Review Advisory Committee: Radiology Predicate Device Product Code: LLZ Predicate Device Requlation Number: 892.2050 Predicate Device Class: II Date Received: 07/16/2001 Decision Date: 07/31/2001 Decision: Substantially Equivalent (SE)

## Device Description

The RemotEye Viewer software product is a feature-rich, diagnostic-level, web-based DICOM medical image viewer that allows downloading, reviewing, interpreting, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. The DICOM images may be physically remote with respect to the viewing client, but reachable through a network.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

## Device Intended Use

The RemotEye Viewer software product is intended to be used as a fully functional, webbased medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format. also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

## Technological Characteristics

Both the RemotEye Viewer and the eFilm Workstation are stand-alone medical imaging software packages which can be used on more than one hardware platform. As long as minimum requirements are met, the user is free to choose his/her own hardware platform. Hardware and software requirements for RemotEye Viewer are described both in the Installation Manual and in the User Manual. Please refer to pages 008 Al - 4, 008 Al - 5, 008_Al - 15, 008_Al - 16 of the 008_Al RemotEye Viewer Installation Manual and pages 007_Al - 6, 007_Al - 7, 007_Al - 8 of the 007_Al RemotEye Viewer User Manual.

## Technological Characteristics in common:

Studies and patients search, Display of grayscale and color DICOM images, On-screen presentation of images with several different layouts, Image navigation, Synchronized series navigation for CT and MR, Textual overlays of main image info, Image zooming, Image panning, Window/level contrast manipulation, Image rotation, Image flipping,

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Image enhancement, Display of references lines, Cine-playback, Distance measurements, Area measurements, Angle measurements, Graphical annotations, Normal print, DICOM print, Image export, DICOM CD/DVD burning, Report creation and viewing, MPR (Multi-Planar Reconstruction).

Different Technological Characteristics:

- RemotEye Viewer is a software product based on a web-enabled architecture. . eFilm Workstation is a traditional Windows native desktop application.
- . RemotEye Viewer is a multi-platform viewer, it can successfully run on Windows, Mac OS X and Linux.

eFilm Workstation is a Windows-only software solution.

- . RemotEye Viewer is a web-based software designed to integrate with an external DICOM archive. No DICOM files are permanently stored on the client PCs by RemotEye Viewer.
eFilm Workstation includes an embedded DICOM server, and stores DICOM files locally on the host PC.

These differences don't constitute any new intended use and don't raise new questions of safety and effectiveness.

# Testing

RemotEye Viewer is tested according the specifications that are documented in 013-139 and 009_Al Verification and Validation document.

Testing is an integral part of NeoLogica's software development process as described in 013-126.

## Conclusions

eFilm Workstation and RemotEye Viewer have similar intended use, typical users, functionality and technological characteristics.

RemotEye Viewer provides some different technological characteristics compared to eFilm Workstation; however these differences neither constitute any new intended use, nor raise any questions that affect safety and effectiveness.

Hence RemotEye Viewer is substantially equivalent to eFilm Workstation.