K111079 · Siemens AG Medical Solutions · LLZ · May 13, 2011 · Radiology
Device Facts
Record ID
K111079
Device Name
SYNGO.VIA WEB VIEWER
Applicant
Siemens AG Medical Solutions
Product Code
LLZ · Radiology
Decision Date
May 13, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
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 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
Device Story
syngo.via WebViewer is a client-server software application for reviewing medical images. It functions as an add-on to the syngo.via system, receiving image data (CT, MR, SC, pdf) via DICOM/HL7 interfaces. The client runs on standard web browsers (IE, Firefox, Safari) on common IT hardware. It supports physician interpretation, evaluation, and treatment planning within healthcare institutions. The device does not store or distribute images between devices. It provides authorized personnel with access to radiological data, facilitating consistent workflow through integration with RIS. It benefits patients by enabling fast, continuous access to diagnostic images for clinical decision-making.
Clinical Evidence
Bench testing only. Verification and validation activities were performed to ensure safety and effectiveness. Testing included adherence to IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 60601-1-4 (safety), and IEC 60601-1-1-6 (usability). Image quality was verified using SMPTE patterns (SMPTE: 1995) and standard compression protocols (ISO 109019-1/JPEG and ISO 154444-1/JPEG2000).
Technological Characteristics
Software-only client-server architecture. Server runs on Windows 2008; client runs on standard web browsers (IE, Firefox, Safari). Supports DICOM and HL7 interfaces. Image compression via JPEG and JPEG2000. Verification via SMPTE patterns. Installed by service engineers on customer-provided IT hardware.
Indications for Use
Indicated for the review, interpretation, and evaluation of medical images (CT, MR, SC, pdf) within healthcare institutions (Radiology, Nuclear Medicine, Cardiology). Not for digital mammography diagnosis. Intended for use by clinicians as an option for the syngo.via system.
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).
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# 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.<br>Number |
|--------------|-----------------------|--------------------------|
| Siemens | syngo.x | K092519 |
| Siemens | InSpace 4D | K062673 |
510(k) for syngo®.via WebViewer
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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,<br>Subset of InSpace 4D |
| Image Processing and Evaluation | Identical to InSpace 4D,<br>Subset of syngo.x |
| Supported Image Types | Superset of InSpace 4D,<br>Subset of syngo.x |
| Image data compression . | Identical to syngo.x,<br>Similar to InSpace 4D |
| User administration | identical |
| User Interface | Identical to InSpace 4D,<br>Similar to syngo.x |
| Hardware | similar to InSpace 4D,<br>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
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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
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# 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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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
