(25 days)
Not Found
No
The document describes a software solution for reviewing medical images and does not mention AI or ML capabilities.
No
The device is described as a software-only solution for reviewing medical images to support diagnosis and treatment planning, not for directly providing therapy.
Yes
The device "supports interpretation and evaluation of examinations" and "supports the physician in diagnosis and treatment planning," explicitly stating its role in the diagnostic process.
Yes
The device description explicitly states, "The system is a software only medical device." It also clarifies that the hardware it runs on is not considered a medical device and is outside the scope of the 510(k).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that syngo.via WebViewer is a software-only solution for reviewing medical images from syngo.via. It supports the interpretation and evaluation of examinations within healthcare institutions.
- Input: The input is described as "DICOM formatted images (CT, MR) and objects (SC, pdf)." These are medical images and related documents, not biological samples.
The device's purpose is to display and facilitate the review of medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via.
The system cannot be used as stand-alone device. It is intended to be an option for syngo.via system only.
syngo.via WebViewer is not intended for storage or distribution of medical images from one medical device to another.
syngo.via WebViewer is a 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 has to ensure HIPPA compliance.
syngo.via WebViewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicins within environments environments.
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 displaying of digital mammography images for diagnosis in the U.S
Product codes
LLZ
Device Description
This premarket notification covers Siemens ' PACS syngo.via WebViewer.
syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via.
The system cannot be used as stand-alone device. It is intended to be an option for syngo via system only.
syngo. via Web Viewer is not intended for storage or distribution of medical images from one medical device to another.
syngo.via WebViewer is a 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 has to ensure HIPPA compliance.
syngo. via Web Viewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
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 displaying of digital mammography images for diagnosis in the U.S
The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.
It supports the physician in diagnosis and treatment planning.
Mentions image processing
Image Processing and Evaluation
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM formatted images (CT, MR) and objects (SC, pdf)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY 1 3 2011
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: .
- . Registration Number:
- Contact Person:
Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany
3002808157
Sven Knoke Regulatory Affairs Manager Telephone: +49 (9131) 84-4687 +49 (9131) 84-2792 Telefax:
Device Name and Classification:
- Trade Name:
- Classification Name:
- Classification Panel:
- CFR Section:
- Device Class:
- Product Code:
Date of submission:
syngo.via WebViewer
Picture Archiving and Communications System
Radiology
21 CFR §892.2050
Class II
LLZ .
March 2011
510(k) for syngo®.via WebViewer
March 29, 2011
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II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUB-STANTIAL EQUIVALENCE DETERMINATION
Device Description and Intended Use:
This premarket notification covers Siemens ' PACS syngo.via WebViewer.
syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via.
The system cannot be used as stand-alone device. It is intended to be an option for syngo via system only.
syngo. via Web Viewer is not intended for storage or distribution of medical images from one medical device to another.
syngo.via WebViewer is a 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 has to ensure HIPPA compliance.
syngo. via Web Viewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
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 displaying of digital mammography images for diagnosis in the U.S
The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.
It supports the physician in diagnosis and treatment planning.
syngo. via Web Viewer 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 security, open interfaces.
Integration:
The Workflow Management enables by integration of any HL7- / DICOMcompatible RIS (IHE Year 5) to the syngo product family consistent workflow within the healthcare organization.
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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 IT 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 client application runs in a standard webbrowser - 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 and validation activities, can be supported.
The herewith described syngo. via Web Viewer supports DICOM formatted images (CT, MR) 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 updates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians.
General Safety and Effectiveness Concerns:
The device labelling contains instructions for use and any necessary cautions and warning, 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 devices: .
| Manufacturer | Predicate Device Name | FDA Clearance.
Number |
|--------------|-----------------------|--------------------------|
| Siemens | syngo.x | K092519 |
| Siemens | InSpace 4D | K062673 |
510(k) for syngo®.via WebViewer
3
The syngo.via WebViewer described in this 510(k) has similar intended use and similar technical characteristics as the devices listed above in regard to the specific functionalities.
| Functionality | Syngo. Web Viewer |
|---|---|
| Manufacturer | identical |
| Intended use | identical to meaning of syngo.x |
| Image communication | Subset of syngo.x, |
| Subset of InSpace 4D | |
| Image Processing and Evaluation | Identical to InSpace 4D, |
| Subset of syngo.x | |
| Supported Image Types | Superset of InSpace 4D, |
| Subset of syngo.x | |
| Image data compression . | Identical to syngo.x, |
| Similar to InSpace 4D | |
| User administration | identical |
| User Interface | Identical to InSpace 4D, |
| Similar to syngo.x | |
| Hardware | similar to InSpace 4D, |
| Similar to syngo.x |
The device was designed according to the QSR compliant design process and passed all necessary verification and validation steps to demonstrate safety and effectiveness.
All software lifecycle aspects are done according to IEC 62304. Safety and hazard considerations are performed according to ISO 14971 and IEC 60601-1-4.
Usability aspects are implemented, verified and validated according to IEC 60601-1-1-6.
Communication with connected medical devices is done via DICOM and HL7 where appropriate.
To ensure proper image quality compression is done according to ISO 109019-1 (JPEG) and ISO 154444-1 (JPEG2000). Furthermore SMPTE Pattern according SMPTE: 1995 is used for verification and validation activities.
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 devices.
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Image /page/4/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a person embracing another person, or a symbol representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Siemens AG Medical Solutions % Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K111079
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: April 13, 2011 Received: April 18, 2011
Dear Mr. Stuiber:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: syngo®.via WebViewer
Indications For Use:
syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via.
The system cannot be used as stand-alone device. It is intended to be an option for syngo.via system only.
syngo.via WebViewer is not intended for storage or distribution of medical images from one medical device to another.
syngo.via WebViewer is a 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 has to ensure HIPPA compliance.
syngo.via WebViewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicins within
environments environments.
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 limited to DrOOM.
The U S the U.S
X Prescription Use AND / OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE) DEV.
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) for syngo®.via WebViewer
510K
March 29, 2011
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