K102150 · Siemens Medical Solutions USA, Inc. · LLZ · Oct 5, 2010 · Radiology
Device Facts
Record ID
K102150
Device Name
SYNGO DYNAMICS, VERSION 9.0
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
LLZ · Radiology
Decision Date
Oct 5, 2010
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® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. syngo® Dynamics is not intended to be used for reading of mammography images.
Device Story
syngo® Dynamics (v9.0) is a software-only Picture Archiving and Communication System (PACS) used by clinicians to manage digital medical images. It accepts, transfers, displays, stores, archives, and manipulates images; supports quantification and report generation. The system integrates with Hospital, Radiology, and Cardiology Information Systems (HIS/RIS/CIS) to facilitate clinical workflows and treatment planning. It supports web-based reporting and is deployed as a software-only solution on customer-provided hardware. Clinicians use the system to review images and reports, which informs diagnostic and treatment decisions. The device benefits patients by enabling efficient access to medical imaging data and structured reports across the healthcare enterprise.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including software unit, integration, and system testing to verify design inputs and validate conformance to intended use. Risk management performed per ISO 14971:2007.
Technological Characteristics
Software-only PACS; runs on customer-provided hardware. Connectivity via DICOM 3.0 and HL7 v2.x. Standards: ISO 14971:2007 (risk), IEC 62304:2006 (software lifecycle), IEC 60601-1-4/1-6, SMPTE RP 133-1991, JPEG (IEC/ISO 10918-1:1994).
Indications for Use
Indicated for acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and report generation. Not indicated for reading mammography images. Intended for use by trained professionals in clinical settings.
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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FDA CDRH DMC
# SIEMENS Received
JUL 2 9 2010 Healthcare
K102 150
# 510(k) Summary
OCT - 5 2010
#### syngo® Dynamics (version 9.0)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
- 1. General Information
Date of Summary Preparation: July 12, 2010 Siemens Medical Solutions USA, Inc. Address: 400 W. Morgan Road Ann Arbor, MI 48108 Registration Number: 1836549 Contact Person: Ms. Yuri Ikeda Quality Engineer, Quality & Regulatory Phone: (734) 205-2442 Fax: (734) 205-2683 Email: yuri.ikeda@siemens.com
#### 2. Device Name and Classification
| Trade Name: | syngo® Dynamics |
|-----------------------|---------------------------------------------|
| | Version 9.0 |
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
#### 3. Substantial Equivalence
The syngo® Dynamics version 9.0, addressed in this premarket modification is substantially equivalent to the following commercially available device:
| Manufacturer | Predicate Device Name | FDA Clearance<br>Number |
|--------------|----------------------------|-------------------------|
| Siemens | syngo Dynamics Version 7.0 | K081018 |
#### 4. Device Description
This premarket notification addresses the Siemens syngo® Dynamics version 9.0 Picture Archiving and Communication System.
syngo® Dynamics is intended to display, process, read, report, communicate, distribute and store digital medical images. The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on.
Siemens Medical Solutions USA, Inc.
400 West Morgan Roid Tel.: +1-734-205-2400 ww.usa.siemens.com/healthcare Ann Arbor, MI 48108 USA
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The hardware itself is not considered a medical device and not in the scope of this 510(k) submission.
syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.
The syngo® Dynamics new release focuses on support of web based reporting. Also, in syngo® Dynamics 9.0, server as well as the workplaces will be offered as "software-only".
#### 5. Intended Use
{
syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
syngo® Dynamics is not intended to be used for reading of mammography images.
#### 6. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
syngo® Dynamics version 9.0 has been modified to add capability for web based reporting as well as providing a complete "software only" solution. syngo® Dynamics version 9.0 has the same intended use and the same fundamental scientific technology as the predicate device.
#### 7. General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.
Siemens Medical Solutions USA, Inc. complies with voluntary standards DICOM Version 3.0, IEC/ISO 10918-1:1994 (JPEG), SMPTE RP 133-1991, ISO 14971:2007, IEC 62304:2006, HL7 Version 2.x, IEC 60601-1-4:2000, and IEC 60601-1-6:2006. Software Unit, Integration and System Testing are performed for verification and validation.
The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction.
Siemens believes that syngo® Dynamics version 9.0 is as safe and effective as its predicate device as it does not introduce new indications for use, raise new
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types of safety and effectiveness, or introduce new technology.
# 8. Conclusion as to Substantial Equivalence
The potential hazards of modifications to the device have been evaluated and controlled as part of the product development process, including risk analysis and design considerations. Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device.
In summary, Siemens is of the opinion that syngo® Dynamics 9.0 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Siemens Medical Solutions, Inc. % Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 25112-1891
OCT 5 2010
Re: K102150
Trade/Device Name: syngo® Dynamics (version 9.0) Regulation Number: 21 CFR 892.2050 · Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 20, 2010 Received: July 29, 2010
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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## Page 2
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,
Signature
David G. Brown, Ph.D. Acting 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 Form
| 510(k) Number (if known): . | |
|-----------------------------|--|
| Device Name: | |
syngo® Dynamics (version 9.0)
Indications for Use:
syngo® Dynamics is a Picture Archiving and Communication System (PACS) Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
syngo@ Dynamics is not intended to be used for reading of mammography images.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 801 Subpart C) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)
Blush L.D. Allen Line David G. Brown~
Division Sign-Off
X
Offica of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102150
Page 1 of _1_
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.
