SYNGO.VIA WEB VIEWER

K130998 · Siemens AG Medical Solutions · LLZ · Jan 3, 2014 · Radiology

Device Facts

• Record ID: K130998
• Device Name: SYNGO.VIA WEB VIEWER
• Applicant: Siemens AG Medical Solutions
• Product Code: LLZ · Radiology
• Decision Date: Jan 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

syngo.via WebViewer is a software-only device indicated for reviewing medical images from syngo.via. It supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments (supported Image types: CT, MR, CR, DR, DX, PET). It is not intended for storage or distribution of medical images. syngo.via WebViewer is an option for the syngo.via system and cannot be run without it. It is client server architecture and the client is intended to run on web clients which are connected to the healthcare institution IT infrastructure where the customer will insure HIPAA compliance. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM. The system is not intended for the display of digital mammography images for diagnosis.

Device Story

syngo.via WebViewer is a software-only PACS extension for the syngo.via system; provides secure access to rendered medical images via web browsers and mobile devices (iPad). Inputs include DICOM-formatted medical images (CT, MR, CR, DR, DX, PET) from the syngo.via system. Operates via client-server architecture within hospital IT infrastructure; accessed by clinicians (Radiology, Nuclear Medicine, Cardiology) for image review and basic manipulation. Includes imaging algorithms (MPR, MIP, VRT, PET/CT, SUV). Output is displayed on standard web browsers or mobile clients; assists clinicians in image interpretation and evaluation. Does not store or distribute images. Benefits include fast, continuous access to radiological data for authorized personnel within the hospital network.

Clinical Evidence

Bench testing only. Software verification and validation (Unit, Integration, and System Test levels) performed according to standards including DICOM, ISO/IEC 15444-1, ISO/IEC 10918-1, HL7, IEC 62304, IEC 62366, ISO 14971, and IEC 60601-1-4.

Technological Characteristics

Software-only PACS; server runs on Windows Server 2008; clients run on standard web browsers (IE, Firefox, Safari) or mobile (iPad iOS 5.0/5.1). Supports DICOM images (CT, MR, CR, DR, DX, PET). Connectivity via standard IT interfaces (DICOM, HL7). Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability).

Indications for Use

Indicated for reviewing medical images (CT, MR, CR, DR, DX, PET) within healthcare institutions for interpretation and evaluation. Not for digital mammography diagnosis.

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

• syngo.via WebViewer (K111079)

Submission Summary (Full Text)

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K 130998
JAN - 3 2014

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### I. GENERAL INFORMATION

# Establishment:

| Address: | Siemens AG, Medical Solutions<br>Henkestrasse 127<br>D-91052 Erlangen<br>Germany |
|----------------------|----------------------------------------------------------------------------------|
| Registration Number: | 3002808157 |
| Contact Person: | Joerg Teiche<br>Telephone: [phone]<br>Telefax: [phone] |

Device Name and Classification:

| • Trade Name: | <i>syngo.via</i> WebViewer |
|-------------------------|---------------------------------------------|
| • Classification Name: | Picture Archiving and Communications System |
| • Classification Panel: | Radiology |
| • CFR Section: | 21 CFR §892.2050 |
| • Device Class: | Class II |
| • Product Code: | LLZ |

Date of submission:

.

.

April 2013

510(k) for syngo®.via WebViewer

December 31, 2013 - '

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#### II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

### Indications for Use:

syngo.via WebViewer is a software-only device indicated for reviewing medical images from syngo via. It supports interpretation and evaluations within healtheare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments (supported Image types: CT, MR, CR, DR, DX, PET). It is not intended for storage or distribution of medical images.

syngo.via WebViewer is an option for the syngo.via system and cannot be run without it. It is client server architecture and the client is intended to run on web clients which are connected to the healtheare institution IT infrastructure where the customer will insure HIPAA compliance. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM.

The system is not intended for the display of digital mammography images for diagnosis.

## Device Description:

The syngo.via WebViewer is a software-based Picture Archiving and Communications System (PACS) used with the syngo.via system. The syngo.via WebViewer provides secure access to rendered medical image data and basic image manipulation through web browsers and mobile devices within the reach of the hospital network.

It extends the syngo.via WebViewer software application previous cleared under K111079. New image types supported are PET and X-Ray images. It also provides functionality for displaying images via a mobile application on an iPad.

### syngo.via WebViewer Data Management:

...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data sceurity, open interfaces.

### Integration:

The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the syngo product family consistent workflow within the healthcare organization.

### Technological Characteristics:

syngo.via WebViewer server part is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common 1T hardware. This hardware has to fulfil the defined requirements. The Software will be installed by Siemens service engineers only.

The backend communication and storage solution is based on Windows 2008 operating system. The client machines are based on standard computer (Mac / Windows PC / Linux PC). The web

510(k) for syngo®.via WebViewer

December 31, 2013

Page 2 of 5

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and mobile client application runs in a standard web browser - such as but not limited to Internet Explorer, Firefox, Safari - please refer to the specification for the complete list of supported web browsers.

Any hardware platform, which complies to the specified minimum hardware and software requirements and with successful installation verification activities, can be supported.

The herewith described syngo.via WebViewer supports DICOM formatted images (CT, MR. CR, DR, DX, PET) and objects (SC, pdf).

The syngo.via WebViewer will be marketed as a software only solution for the end-user (with recommended hardware requirements). The server part will be installed by trained service engineers only. Any special needs such as integration in a specific environment and undates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians.

#### Summary of Non-Clinical Tests

The software verification and validation (Unit Test Level. Integration Test Level and System Test Level) was performed for all newly developed components and the complete system according to the following standards:

- DICOM Standard [2011] -
- ISO/IEC 15444-1:2005+TC 1:2007 -
- ISO/IEC 10918-1:1994 + TC 1:2005 -
- HL7 [2006] -
- IEC 62304:2006 -
- -IEC 62366:2007
- -ISO 14971:2007
- -IEC 60601-1-4:2000

#### General Safety and Effectiveness Concerns:

The device labelling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize hazards, Siemens adheres to recognized and established industry practice and standards.

### Substantial Equivalence:

The syngo.via Web Viewer, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

December 31, 2013

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| Manufacturer | Predicate Device Name | FDA Clearance<br>Number |
|--------------|-----------------------|-------------------------|
| Siemens | syngo.via WebViewer | K111079 |

The syngo.via Web Viewer described in this 510(k) has similar intended use and similar technical characteristics as the device listed below in regard to the specific functionalities.

| Functionality | syngo.via WebViewer VAI1 | syngo.via WebViewer VA10A |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | identical | identical |
| Intended use | syngo.via WebViewer is a software-<br>only device indicated for reviewing<br>medical images from syngo.via.<br>It supports interpretation and evalu-<br>ation of examinations within<br>healthcare institutions, for example,<br>in Radiology, Nuclear Medicine<br>and Cardiology environments (sup-<br>ported Image types: CT, MR, CR,<br>DR, DX, PET). It is not intended<br>for storage or distribution of medi-<br>cal images.<br>syngo.via WebViewer is an option<br>for the syngo.via system and cannot<br>be run without it. It is client server<br>architecture and the client is in-<br>tended to run on web clients which<br>are connected to the healthcare in-<br>stitution IT infrastructure where the<br>customer will insure HIPAA com-<br>pliance.<br>The communication of syngo.via<br>WebViewer with connected medi-<br>cal IT systems will be done via<br>standard interfaces such as but not<br>limited to DICOM.<br>The system is not intended for the<br>display of digital mammography<br>images for diagnosis. | syngo.via WebViewer is intended to<br>be a software-only solution for re-<br>viewing medical images from syn-<br>go.via.<br>The system cannot be used as stand-<br>alone device. It is intended to be an<br>option for syngo.via system only.<br>syngo.via WebViewer is not intended<br>for storage or distribution of medical<br>images from one medical device to<br>another.<br>syngo.via WebViewer is a client<br>server architecture and the client is<br>intended to run on web clients which<br>are connected to the healthcare insti-<br>tution IT infrastructure where the<br>customer has to ensure HIPAA com-<br>pliance.<br>syngo.via WebViewer supports inter-<br>pretation and evaluation of examina-<br>tions within healthcare institutions,<br>for example, in Radiology, Nuclear<br>Medicine and Cardiology environ-<br>ments.<br>The communication of syngo.via<br>WebViewer with connected medical<br>IT systems will be done via standard<br>interfaces such as but not limited to<br>DICOM.<br>The system is not intended for the |

Device Comparison Table between new device and predicate device:

510(k) for syngo®.via WebViewer

December 31, 2013

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| Functionality | syngo.via WebViewer VA11 | syngo.via WebViewer VA10A |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | | displaying of digital mammography<br>images for diagnosis in the U.S |
| Image<br>com-<br>munication | identical | identical |
| Image<br>Processing and<br>Evaluation | identical | identical |
| Supported Im-<br>age Types | MR, CT, SC, PDF, PET, CR, DX | MR, CT, SC, PDF |
| Image<br>data<br>compression | identical | identical |
| User admini-<br>stration | UI is syngo®-based web client and<br>mobile client | UI is syngo®-based web client |
| User<br>Interface | identical | identical |
| Hardware | Client: PC with Windows System<br>or MAC with Mac iOS Server:<br>Windows Server 2008 SP1<br>iPad (with iOS 5.0 or 5.1) | Client: PC with Windows System,<br>MAC with Mac OS Server: Windows<br>Server 2008 |
| Imaging Algo-<br>rithms | MPR, MIP, VRT, PET/CT, SUV | MPR, MIP, VRT |
| Quantitative<br>Algorithms | identical | identical |

In summary, Siemens is of the opinion that syngo.via WebViewer does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.

.

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes or lines, possibly representing human figures or abstract forms.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

January 3, 2014

Siemens AG, Medical Solutions % Ms. Sabine Schroedel Regulatory Affairs Manager Henkestrasse 127 Erlangen, Bavaria 91052 GERMANY

Re: K130998

Trade/Device Name: syngo.via WebViewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 19, 2013 Received: December 20, 2013

Dear Ms. Schroedel:

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K130998

# Device Name

syngo®.via WebViewer

### Indications for Use (Describe)

syngo.via WebViewer is a software-only device indicated for reviewing medical innages from syngo.via. It supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments (supported Image types: CT, MR, CR, DR, DX, PET). It is not intended for storage or distribution of medical images.

syngo.via WebViewer is an option for the syngo.via system and cannot be run without it. It is client server architecture and the client is intended to run on web clients which are connected to the healtheare institution IT infrastructure where the customer will insure IIIPAA compliance.

The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM.

The system is not intended for the display of digital manimography images for diagnosis.

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

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Smh.7)

FORM FDA 3881 (9/13)

PSC Publishing Services [phone] EG

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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