It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo .via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Device Description

Siemens Healthcare GmbH intends to market the Picture Archiving and Communications System, syngo.via. software version VB40A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via, software version VB10A.

syngo.via is a software only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via and therefore not in the scope of this 510(k) submission.

syngo.via provides tools and features to cover the radiological tasks reading images and reporting. syngo.via supports DICOM formatted images and objects. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite, syngo.via interoperates with a Radiology Information System (RIS) to enable customer specific workflows.

syngo.via is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage, and incorporates the local database. The client provides the user interface for interactive image viewing and can be installed and started on each workplace that has a network connection to the server.

The server's backend communication and storage solution is based on Microsoft Windows server operating systems. The client machines are based on Microsoft Windows operating systems.

syngo.via supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device, syngo.via, software version VB40A, as well as the predicate device, syngo.via, software version VB10A.

AI/ML Overview

This document describes the 510(k) summary for syngo.via (Version VB40A), a Picture Archiving and Communications System developed by Siemens Healthcare GmbH. The submission asserts substantial equivalence to the predicate device, syngo.via (Version VB10A).

The document states that a study was conducted to demonstrate the substantial equivalence of the new device by focusing on verification and validation testing of the modifications. However, it does not provide detailed acceptance criteria and reported device performance in a table format. Nor does it detail a specific study with sample sizes, data provenance, expert qualifications, or adjudication methods for proving the device meets acceptance criteria.

Here's an attempt to extract and synthesize the information based on the provided text, recognizing the limitations of the submission's detail:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria or specific reported device performance in a quantitative manner. Instead, it makes a qualitative claim about the modifications:

"The software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."

And for specific features compared against the predicate:
"The changes between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device."

The document primarily focuses on verifying that new features and system updates (like operating system support, cyber security enhancements, and improvements to existing algorithms) do not negatively impact safety and effectiveness and perform comparably to the predicate device. The acceptance criteria would broadly relate to demonstrating functionality, safety, and effectiveness equivalent to the cleared predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Non-clinical tests were conducted for the device syngo.via during product development. The modifications described in this Premarket Notification were supported with verification and validation testing." And "Performance tests were conducted to test the functionality of the device syngo.via."

However, no specific information is provided regarding:

The sample size used for the test set (number of images, cases, or tests)
The data provenance (e.g., country of origin, whether the data was retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The submission describes software verification and validation, but not clinical performance studies involving expert readers to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in this submission. The device (syngo.via) is described primarily as a viewing, manipulation, communication, and storage system for medical images, with enhancements to existing imaging algorithms (e.g., Cinematic VRT, Organ Segmentation) and user interface improvements. It explicitly states: "No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel." Therefore, it is unlikely an MRMC study comparing human readers with and without AI assistance was conducted for this particular clearance, as the device itself does not offer AI-driven diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes "Imaging algorithms" such as:

Multiplanar reconstruction (MPR)
Maximum and Minimum Intensity Projection (MIP/MinIP)
Volume Rendering Technique (VRT) with additional technique Cinematic VRT
Organ segmentation based on existing ALPHA technology
Change Visualization
Automatic Spine Labeling, also for ribs in CT thorax scans (“Rib labeling”)

It states that "There are enhancements to the existing algorithms in the subject device compared to the predicate device." While these are algorithms, the submission treats them as enhancements to an imaging workstation rather than standalone diagnostic algorithms requiring separate "standalone performance" metrics in the way a CAD system might. The performance of these algorithms would have been assessed during the "Non-clinical Performance Testing" and "Software Verification and Validation" as mentioned, to ensure they function as intended and do not impact safety or effectiveness. However, no specific metrics for standalone performance (e.g., sensitivity, specificity for organ segmentation outside the context of human interpretation) are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used, as it does not detail specific performance studies involving diagnostic accuracy or clinical outcomes. The "ground truth" for software verification and validation would typically be established based on functional requirements, design specifications, and successful execution of tests.

8. The sample size for the training set

The document does not provide information about a training set size. This submission is for an updated version of a Picture Archiving and Communications System (PACS) and does not describe the development or training of new AI/ML models in a way that would typically involve a separate "training set." The Mention of "Organ segmentation based on existing ALPHA technology" suggests it might leverage pre-existing technology, but no details on its training are given for this submission.

9. How the ground truth for the training set was established

Since no training set information is provided (as per point 8), details on how its ground truth was established are also not available in the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 16, 2019

Siemens Healthcare GmbH % Mr. Georg Bauer Responsible Third-Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112

Re: K191040

Trade/Device Name: syngo.via (Version VB40A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 17, 2019 Received: April 19, 2019

Dear Mr. Bauer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191040

Device Name syngo.via (Version VB40A)

syngo.via is a software solution intended to be used for viewing, manipulation, and storage of medical images.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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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.

Date prepared: April 03, 2019

1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
  Establishment Registration Number: 3004977335

2. Contact Person:

Mr. Elango Alampalayam Rangappan Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: ar.elango@siemens-healthineers.com Telephone: +49 (9191) 18-4429 Fax: +49 (9191) 18-4404

3. Device Name and Classification:

Trade Name:	syngo.via (Version VB40A)
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ

4. Legally Marketed Predicate Device:

Trade Name:	syngo.via (Version VB10A)
510(k) Clearance:	K150843
Clearance Date:	April 25, 2015
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ
Recall Information:	This predicate device has not been the subject of any design related recalls.

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5. Device Description:

The server's backend communication and storage solution is based on Microsoft Windows server operating systems. The client machines are based on Microsoft Windows operating systems.

syngo.via supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

6. Intended Use:

syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo. via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

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7. Summary of Differences between the Subject Device and the Predicate Device:

The differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table:

22 syngo via VB (0A was manufactured by Siement Solutions during the time of its filing. Late-on legal manufacturer change was performed to Siemens Healthcare GmbH. So finally, the legal manufacturer is identical for both devices.

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23 Rib Labeling as a functionality was already covered by a 510(k) clearance with device syngo.CT Bone Reading, K123584.

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8. Non-clinical Performance Testing:

Non-clinical tests were conducted for the device syngo.via during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthcare GmbH claims conformance to the following standards:

NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in Medicine (DI--COM) Set
ISO/IEC 10918-1 First edition 1994-02-15 + Technical Corrigendum 1 (2005) -(JPEG)
ISO/IEC 15444-1:2016 (JPEG2000) -
ISO 14971 Second edition 2007-03-01 -
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION -
-IEC 82304-1 Edition 1.0 2016-10
IEC 62366-1 Edition 1.0 2015-02 -
IEEE Std 3333.2.1-2015 -
ISO/HL7 21731:2014 (Version 2.x) -

Software Verification and Validation:

Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.via during product development.

The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device syngo.via.

Summary:

Performance tests were conducted to test the functionality of the device syngo.via. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.

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9. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.

The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

10. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.

In summary, we are of the opinion that the subject device syngo.via, software version VB40A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.

Regulation Number and Section

§ 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).

	Subject device	Predicate device	Comparison	Impact to Safety & Effec-tiveness
Device name andversion (K number)	syngo.via (Version VB40A)	syngo.via (Version VB10A)(K150843)	New product version	NA
Manufacturer	Siemens Healthcare GmbH	Siemens AG Medical Solutions	Legal manufacturerchange22.	NA
Intended use	syngo.via is a software solution in-tended to be used for viewing, manipu-lation, communication, and storage ofmedical images.It can be used as a stand-alone deviceor together with a variety of clearedand unmodified syngo based softwareoptions.syngo.via supports interpretation andevaluation of examinations withinhealthcare institutions, for example, inRadiology, Nuclear Medicine andCardiology environments.The system is not intended for the dis-playing of digital mammography im-ages for diagnosis in the U.S.	syngo.via is a software solution in-tended to be used for viewing, manipu-lation, communication, and storage ofmedical images.It can be used as a stand-alone deviceor together with a variety of clearedand unmodified syngo based softwareoptions.syngo.via supports interpretation andevaluation of examinations withinhealthcare institutions, for example, inRadiology, Nuclear Medicine andCardiology environments.The system is not intended for the dis-playing of digital mammography im-ages for diagnosis in the U.S.	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
Software architecture	Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules.	Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules.	Same	NA
Image communication	Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image transfer protocol for use inside syngo.via between the client and server.	Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image transfer protocol for use inside syngo.via between the client and server.	Same	NA
Imaging algorithms	Multiplanar reconstruction (MPR)Maximum and Minimum Intensity Projection (MIP/MinIP)Volume Rendering Technique (VRT) with additional techniqueCinematic VRT for photorealistic renderingShaded Surface Display (SSD)Editor functionality (e.g. ClipBox)RegistrationAnatomical registrationRegion growing with single click region growingOrgan segmentation based on existing ALPHA technology.Change VisualizationAutomatic Spine Labeling, also for ribs in CT thorax scans13 (“Rib labeling”)	Multiplanar reconstruction (MPR)Maximum and Minimum Intensity Projection (MIP/MinIP)Volume Rendering Technique (VRT)Shaded Surface Display (SSD)Editor functionality (e.g. ClipBox)RegistrationAnatomical registrationRegion growingAutomatic Spine Labeling, also for ribs in CT thorax scans23 (“Rib labeling”)	There are enhancements to the existing algorithms in the subject device compared to the predicate device.cVRT: Cinematic VRT is an extension to the standard VRT rendering algorithm to visualize the photorealistic images.Organ Segmentation: Organ Segmentation is an enhancement based on the existing but improved ALPHA technology to visualize the anatomical regions Heart, Lung and Aorta.Change Visualization: This algorithm helps to visualize the anatomical changes	The changes between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device.
	Subject device	Predicate device	Comparison	Impact to Safety & Effec-tiveness
			in the lung region betweentwo series belonging todifferent time points.
Quantitative algo-rithms	Distance and angle measurements	Distance and angle measurements	Same	NA
Supported ImageGenerating Modali-ties	The following Image types are sup-ported by syngo.via:- CT Image (Computed Tomogra-phy)- MR Image (Magnetic Resonance)- NM Image (Nuclear Medicine)- XA Image (X-Ray Angiography)- US Image (Ultrasound)- DX Image (Digital Radiography)- DICOM secondary capture objects	The following Image types are sup-ported by syngo.via:- CT Image (Computed Tomogra-phy)- MR Image (Magnetic Resonance)- NM Image (Nuclear Medicine)- XA Image (X-Ray Angiography)- US Image (Ultrasound)- DX Image (Digital Radiography)- DICOM secondary capture objects	Same	NA
Image data Com-pression	Receive & Store:Images are received and stored as re-ceived without any change in the com-pression format.Display:The images are displayed as receivedwithout any change in the compres-sion.Lossy compression images are dis-played with an indication to the userwith the compression ratio.Export:To DICOM node and Exchangeablemedia: Images are sent as per the DI-	Receive & Store:Images are received and stored as re-ceived without any change in the com-pression format.Display:The images are displayed as receivedwithout any change in the compres-sion.Lossy compression images are dis-played with an indication to the userwith the compression ratio.Export:To DICOM node and Exchangeablemedia: Images are sent as per the DI-	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
	COM negotiation and depending onCompression settings. Lossy compres-sion is not supported.	COM negotiation and depending onCompression settings. Lossy compres-sion is not supported.
	Supported Compressions for export:lossless compression algorithms,JPEG, JPEG 2000 and RLE.	Supported Compressions for export:lossless compression algorithms,JPEG, JPEG 2000 and RLE.
Operating system	Client:Microsoft Windows 7 SP1 or Mi-crosoft Windows 8.1 or MicrosoftWindows 10Server:Microsoft Windows Server 2008 R2 orMicrosoft Windows Server 2012 R2.or Microsoft Server 2016	Client:Microsoft Windows 7 SP1 or Mi-crosoft Windows 8.1Server:Microsoft Windows Server 2008 R2 orMicrosoft Windows Server 2012 R2	In the subject device clientsupports the MicrosoftWindows 10 Operatingsystem and Server supportsMicrosoft Windows Server2016 additionally com-pared to the predicate de-vice.	This Operating System dif-ference between the predi-cate device and the subjectdevice doesn't impact thesafety and effectiveness ofthe subject device as thenecessary measures taken forthe safety and effectivenessof the subject device.
Impact on ImageGenerating Devices	Nonesyngo.via is a pure post processingsoftware and no influence on the im-age generating devices.	Nonesyngo.via is a pure post processingsoftware and no influence on the im-age generating devices.	NA as both the devices donot impact the Image gen-erating devices.	NA
CAD Functionali-ties	None.No automated diagnostic interpretationcapabilities like CAD are included. Allimage data are to be interpreted bytrained personnel.Note: The LungCAD Navigation Toolprovides the user interface to visualizethe results of the external LungCADalgorithm which is cleared with syn-go.CT LungCAD as an accessory(K143196).	None.No automated diagnostic interpretationcapabilities like CAD are included. Allimage data are to be interpreted bytrained personnel.	NA as both the devicesdon't support any CADfunctionalities.Note for Subject device:The LungCAD Navigationtool doesn't provide anyCAD Functionality ratheronly provides the user in-terface to view the resultsgenerated by externalLungCAD algorithm.	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effec-tiveness
Software self-test /checks	Indicates the user in case that datacoming from an interface cannot beassigned to a task flow to assign itmanually.In case of a data mismatch due to in-correct or inconsistent use of DICOMrules the administrator can change thedata transfer protocol and patientidentification rules (DICOM ParserTool).When the audit trail folder exceeds theconfigured level of storage, a warningmessage is sent to the administrator bye-mail, if configured.Client installation is prevented auto-matically in case if the system doesn'thave the recommended operating sys-tem. Also during the launch of theclient every time, the compatibility tothe server version is checked and re-quest to update/upgrade to client incase of mismatch.Database recovery tool restores thedata if the integrity checks betweenthe Short term Storage and syngo.viadatabase fails.A new instance of DICOM object iscreated in case of any non-reversiblemodification is performed on the DI-COM Object (e.g. Lossy compres-sion, reduction of color depth.	Indicates the user in case that datacoming from an interface cannot beassigned to a task flow to assign itmanually.In case of a data mismatch due to in-correct or inconsistent use of DICOMrules the administrator can change thedata transfer protocol and patientidentification rules (DICOM ParserTool).When the audit trail folder exceeds theconfigured level of storage, a warningmessage is sent to the administrator bye-mail, if configured.Client installation is prevented auto-matically in case if the system doesn'thave the recommended operating sys-tem. Also during the launch of theclient every time, the compatibility tothe server version is checked and re-quest to update/upgrade to client incase of mismatch.Database recovery tool restores thedata if the integrity checks betweenthe Short term Storage and syngo.viadatabase fails.A new instance of DICOM object iscreated in case of any non-reversiblemodification is performed on the DI-COM Object (e.g. Lossy compres-sion, reduction of color depth.	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effec-tiveness
	resampling of image matrix, etc.)	resampling of image matrix, etc.)
Cyber Security	- User access control- Audit trails- Documentation of system securityinformation, Network traffic &Firewall control- Support of virus / malware protec-tion.- System Hardening- Device guard	- User access control- Audit trails- Documentation of system securityinformation, Network traffic &Firewall control- Support of virus / malware protec-tion.	The security of the systemwas increased over theyears by introducing theSystem Hardening and theDevice Guard.	The new security functionsdon't impact the safety andeffectiveness of the subjectdevice as the necessarymeasures taken for the safetyand effectiveness of the sub-ject device.
Hardware	Hardware is not understood as part ofthe medical device, but needs to com-ply with the minimum requirements asspecified by syngo.via.	Hardware is not understood as part ofthe medical device, but needs to com-ply with the minimum requirements asspecified by syngo.via.	Same	NA
Software functionalities
Workflow control	Workflows support the user in prepar-ing images for examination. Based oninformation such as modality andbody part, syngo.via assigns work-flows to studies.	Workflows support the user in prepar-ing images for examination. Based oninformation such as modality andbody part, syngo.via assigns work-flows to studies.	Same	NA
Graphical user in-terface	Yes, with reduced color palette, clear-er structure and text labels on icons.Floating panels increases the userfriendliness as the user can move thepanels wherever they are convenientwith.	Yes, with reduced color palette, clear-er structure and text labels on icons	In compared to the predi-cate device, the subjectdevice has the option tomove certain panels (e.g.Favorite Tools) whereverhe/she wants to. Thisgives greater flexibility tothe user.	This difference between thepredicate device and thesubject device doesn't im-pact the safety and effec-tiveness of the subject de-vice as the necessarymeasures taken for the safe-ty and effectiveness of thesubject device.
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
Image text	Yes, with Interactive Image text and configurable settings.	Yes, with additional configurable settings.	In the subject device there is an additional functionality that the selective image texts can be manipulated with mouse click and scroll.	This difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device.
Patient Browser	Yes, with simplified search functionality, clearer structure of search results, unlimited search results, periodic updates of search results, image preview and flexible floating patient browser window.	Yes, with simplified search functionality, clearer structure of search results, unlimited search results, periodic updates of search results, image preview and flexible floating patient browser window.	Same.	This difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device.
Series navigator	Yes, the Series Navigator lists all currently loaded data within a workflow.Series Navigator supports the Thumbnail view and switching between Preview, List and Thumbnail views for both series and instances level.	Yes, the Series Navigator lists all currently loaded data within a workflow.	The subject device supports the Thumbnail views for Series and Instances and the user can switch between the List, Preview and Thumbnail views.	NA
Findings navigator / Findings Assistant	Yes, Findings Assistant lists all measurements, graphical objects, annotations, and snapshots. Additionally the user can create new findings, edit findings, trend findings over time,	The Findings Navigator lists all measurements, graphical objects, annotations, and snapshots.	Findings Navigator from the predicate device is renamed with Findings Assistant with the improvements like create findings, edit findings	This difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
	cluster findings based on body region.		findings trending, andcluster findings.	measures taken for the safety and effectiveness of the subject device.
Reporting	Yes, with functionality to create onepage reports, insert snapshot images,customize reports, and data export invarious formats. Also with edit optionof the attributes of findings in the report editor & trend findings over time.The automation of the supportedguidelines is filled on its own for easyreference of the user. The integrationof the findings export with NuancePowerscribe 360 is enabled.	Yes, with functionality to create onepage reports, insert snapshot images,customize reports, and data export invarious formats.	There are some minor improvements to the existingreporting functionalitylike standard guidelineautomation based on userentries, interfacing withexternal reporting applications, findings trending.	This difference between thepredicate device and thesubject device doesn't impact the safety and effectiveness of the subject device as the necessarymeasures taken for the safety and effectiveness of the subject device.
Correct and rearrange	Yes, for administrative users, correction capabilities and rearranging of data are added.	Yes, for administrative users, correction capabilities and rearranging of data are added.	Same	NA
Import and exportof data	Import of DICOM data from networknodes or external media, and of DI-COM-compliant or non DICOM-compliant data from external mediaand Windows file system.Export to CD/DVD, Windows filesystem, or other DICOM nodes.	Import of DICOM data from networknodes or external media, and of DI-COM-compliant or non DICOM-compliant data from external mediaand Windows file system.Export to CD/DVD, Windows filesystem, or other DICOM nodes.	Same	NA
Archiving data	Data can be sent to an archive if syn-go.via is connected to a PACS or corresponding DICOM node.	Data can be sent to an archive if syn-go.via is connected to a PACS or corresponding DICOM node.	Same	NA
Ranges	Yes, parallel, radial, Radial sliced,Curved and Spine ranges are support	Yes, parallel, radial, Radial sliced,Curved and Spine ranges are support	Same	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effec-tiveness
	ed. Additionally supported all theRanges with anatomical range presetsfor CT and MR images.	ed. Additionally supported all theRanges with anatomical range presetsfor CT and MR images.
Spine/Rib labeling	Yes, with suggested spine labels to beconfirmed by the user, and additionalsmart placement of labels, also in in-ter-vertebra regions, support of 2Dimages, support of multi-series stud-ies, and added support for rib labels.	Yes, with suggested spine labels to beconfirmed by the user, and additionalsmart placement of labels, also in in-ter-vertebra regions, support of 2Dimages, support of multi-series stud-ies, and added support for rib labels.	Same	NA
Communication	Yes, Interface with DICOM, HL7 ispossible.	Yes, Interface with DICOM, HL7 ispossible.	Same	NA
Printing	Yes, with support to print image text,apply same zoom factor for all select-ed images and selection of DICOMprinter or paper printer. Also the di-rect printing from Patient browser ispossible now and the administratorcan configure a default printer for theclient instead of user.	Yes, with support to print image textand selection of DICOM printer orpaper printer.	The improvements includethe interactive zoom, di-rect printing from Patientbrowser and local printerconfiguration in clients.	This difference between thepredicate device and thesubject device doesn't im-pact the safety and effec-tiveness of the subject de-vice as the necessarymeasures taken for the safe-ty and effectiveness of thesubject device.
Online help system	Yes, with search, indexing, filtering,library function, document collec-tions, and user-generated content.	Yes, with search, indexing, filtering,library function, document collec-tions, and user-generated content.	Same	NA
Markers and anno-tations	Yes,with support for marking a posi-tion on an image and textual an-	Yes,with support for marking a posi-tion on an image and textual an-	Same	NA
Subject device	Predicate device	Comparison	Impact to Safety & Effec-tiveness
notations.	notations.
- with added textual and graphicalannotations, improved placementof measurement text, andchanged numbering of markers.	- with added textual and graphicalannotations, improved placementof measurement text, andchanged numbering of markers.