syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology.

Device Description

syngo.via View&GO 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 View&GO and therefore not in the scope of this 510(k) submission.

syngo.via View&GO provides tools and features to cover the radiological tasks preparation for reading, reading images and support reporting. syngo.via View&GO supports DICOM formatted images and objects.

syngo.via View&GO is a standalone viewing and reading workplace. This is capable of rendering the data from the connected modalities for the post processing activities. syngo.via View&GO provides the user interface for interactive image viewing and processing with a limited short-term storage which can be interfaced with any Long-term storage (e.g. PACS) via DICOM syngo.via View&GO is based on Microsoft Windows operating systems.

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

AI/ML Overview

The provided text is a 510(k) Summary for the Siemens Healthcare GmbH device "syngo.via View&GO" (Version VA30A). This document focuses on demonstrating substantial equivalence to a predicate device (syngo.via View&GO, Version VA20A) rather than presenting a detailed study of the device's performance against specific acceptance criteria for a novel algorithm.

The document states that the software is a Medical Image Management and Processing System, and its purpose is for "image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology." It specifically states, "No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel."

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving an algorithm meets those criteria for diagnostic performance. It does not describe an AI/ML algorithm or its associated performance metrics.

However, based on the provided text, I can infer some aspects and highlight what information is missing if this were an AI-driven diagnostic device.

Here's an analysis based on the assumption that if this were an AI-based device, these fields would typically be addressed:

Summary of Device Performance (Based on provided text's limited scope for a general medical image processing system):

Since "syngo.via View&GO" is a medical image management and processing system without automated diagnostic interpretation capabilities, the acceptance criteria and performance data would revolve around its functionality, usability, and safety in handling and presenting medical images. The provided text primarily establishes substantial equivalence based on the lack of significant changes in core functionality and the adherence to relevant standards for medical software and imaging.

1. Table of acceptance criteria and the reported device performance:

The document doesn't provide a table of performance metrics for an AI algorithm. Instead, it describes "Non-clinical Performance Testing" focused on:

Conformance to standards (DICOM, JPEG, ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1, IEEE Std 3333.2.1-2015).
Software verification and validation (demonstrating continued conformance with special controls for medical devices containing software).
Risk analysis and mitigation.
Cybersecurity requirements.
Functionality of the device (as outlined in the comparison table between subject and predicate device).

Reported Performance/Findings (General):

"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."
"Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence."
The device "does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device."

Example of what a table might look like if this were an AI algorithm, along with why it's not present:

Acceptance Criterion (Hypothetical for AI)	Reported Device Performance (Hypothetical for AI)
Primary Endpoint: Sensitivity for detecting X > Y%	Not applicable - device has no diagnostic AI.
Secondary Endpoint: Specificity for detecting X > Z%	Not applicable - device has no diagnostic AI.
Image Rendering Accuracy (e.g., visual fidelity compared to ground truth)	"All the software specifications have met the acceptance criteria." (general statement)
DICOM Conformance	Conforms to NEMA PS 3.1-3.20 (2016a)
User Interface Usability (e.g., according to human factors testing)	Changes are "limited to the common look and feel based on Siemens Healthineers User Interface Style Guide." "The changes... doesn't impact the safety and effectiveness... of the subject device."
Feature Functionality (e.g., MPR, MIP/MinIP, VRT, measurements)	"Algorithms underwent bug-fixing and minor improvements. No re-training or change in algorithm models was performed." "The changes... doesn't impact the safety and effectiveness... of the subject device."

2. Sample size used for the test set and the data provenance:

Not explicitly stated for diagnostic performance, as the device does not have automated diagnostic capabilities.
The software verification and validation activities would involve testing with various DICOM images to ensure proper rendering and processing. The exact number of images or datasets used for these software tests is not detailed.
Data Provenance: Not specified, as it's not a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not stated. Ground truth for diagnostic accuracy is not established for this device, as it does not perform automated diagnosis. The ground truth for software functionality would be the expected behavior of the software according to its specifications.

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

Not applicable. No clinical adjudication method is described, as this is neither a clinical study nor an AI diagnostic device.

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:

No, an MRMC study was NOT done/described. The device explicitly states it has "No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel." Therefore, it does not offer AI assistance for diagnosis.

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

Not applicable. The device is a "Medical Image Management and Processing System" that provides tools for human interpretation; it is not a standalone diagnostic algorithm.

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

Not applicable for diagnostic purposes. For software functionality, the ground truth is the defined behavior as per the software specifications and design.

8. The sample size for the training set:

Not applicable/Not stated. The document explicitly states for the "Imaging algorithms" section that "No re-training or change in algorithm models was performed." This implies that the algorithms are traditional image processing algorithms, not machine learning models that require training data in the context of diagnostic AI. If there were any minor algorithmic adjustments, the training data for such classical algorithms is typically the mathematical formulation itself rather than a dataset of clinical cases for machine learning.

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

Not applicable. As indicated above, there is no mention of "training" in the context of machine learning. The algorithms are described as undergoing "bug-fixing and minor improvements" but no "re-training or change in algorithm models."

Summary

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Image /page/0/Picture/0 description: The image shows 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.

Siemens Healthcare GmBH Frederike Jakob Regulatory Affairs Manager Siemensstraße 1, Forchheim Erlangen, Bavaria Germany

Re: K221501

October 14, 2022

Trade/Device Name: syngo.via View&GO Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 14, 2022 Received: September 15, 2022

Dear Frederike Jakob:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221501

Device Name syngo.via View&GO VA30A

Indications for Use (Describe)

syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: June 29, 2022

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

2. Contact Person:

Ms. Frederike Jakob Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: Frederike.Jakob(@siemens-healthineers.com Telephone: +49 (0)162 109 2694 Fax: +49 (9191) 18-4404

3. Device Name and Classification:

Trade Name:	syngo.via View&GO (Version VA30A)
Classification Name:	Medical Image Management and Processing System (PACS)
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 View&GO (Version VA20A)
510(k) Clearance:	K201477
Clearance Date:	July 1, 2020
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 anydesign related recalls.

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5. Device Description:

Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA30A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via View&GO, software version VA20A.

syngo.via View&GO 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 View&GO, software version VA30A, as well as the predicate device, syngo.via View&GO, software version VA20A.

6. Intended Purpose:

6.1 Intended Use

syngo.via View&GO 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 View&GO 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.

The subject device and the predicate device share an identical intended use.

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6.2 Indications for Use

syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology.

The subject device and the predicate device share identical indications for use. The indications for use fall within the scope of the intended use.

6.3 Contraindications

The system is not indicated for mammography images for diagnosis in the U.S. The application is not to be used as an archiving device for patients' image data. The application is not to be used as a sole basis for clinical decisions but further evidence has to be taken into account.

The subject device and the predicate device share substantially identical contraindications.

6.4 Patient Target Population

syngo.via View&GO has neither limitations concerning the patient population (e.g. age, weight, health, condition) nor limitations concerning region of body or tissue type.

The patient target population is identical for the subject device and the predicate device.

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

The following table compares the functionality of syngo.via View&GO VA30A to the predicate device syngo.via View&GO VA20A:

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1 Rib Labeling as a functionality was already covered by a 510(k) clearance with device SYNGO, CT BONE READING, K123584.

² Rib Labeling as a functionality was already covered by a 510(k) clearance with device SYNGO, CT BONE READING, K123584.

510(k) Summary for syngo.via View&GO VA30A

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3 Range Presets as a functionality was already covered by a 510(k) clearance with device syngo.via (version VB40A), K191040

4 Range Presets as a functionality was already covered by a 510(k) clearance with device syngo.via (version VB40A), K191040

510(k) Summary for syngo.via View&GO VA30A

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Table 1: Substantial equivalency information

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8. Non-clinical Performance Testing:

Non-clinical tests were conducted for the device syngo.via View&GO 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 (2016a) Digital Imaging and Communications in Medicine -(DICOM) 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 -

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 View&GO 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 View&GO.

Summary:

Performance tests were conducted to test the functionality of the device syngo.via View&GO. 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 View&GO, software version VA30A, 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 toSafety &Effectiveness
Device nameand version (Knumber)	syngo.via View&GO(Version VA30A)	syngo.via View&GOVersion VA20A(K201477)	New productversion	NA
Manufacturer	Siemens HealthcareGmbH	Siemens HealthcareGmbH	Identical	NA
Intended use	syngo.via View&GO isa software solutionintended to be used forviewing, manipulation,communication, andstorage of medicalimages.It can be used as astand-alone device ortogether with a varietyof cleared andunmodified syngo basedsoftware options.syngo.via View&GOsupports interpretationand evaluation ofexaminations withinhealthcare institutions,for example, inRadiology, NuclearMedicine andCardiologyenvironments.The system is notintended for thedisplaying of digitalmammography imagesfor diagnosis in the U.S.	syngo.via View&GO isa software solutionintended to be used forviewing, manipulation,communication, andstorage of medicalimages.It can be used as astand-alone device ortogether with a varietyof cleared andunmodified syngo basedsoftware options.syngo.via View&GOsupports interpretationand evaluation ofexaminations withinhealthcare institutions,for example, inRadiology, NuclearMedicine andCardiologyenvironments.The system is notintended for thedisplaying of digitalmammography imagesfor diagnosis in the U.S.	Identical	NA
Softwarearchitecture	Standalone workplacesystem that is logicallybroken down tosyngo.via View&GOsubsystems.Subsystems are furtherbroken down to syngosoftware options.	Standalone workplacesystem that is logicallybroken down tosyngo.via View&GOsubsystems.Subsystems are furtherbroken down to syngosoftware options.	Identical	NA
	Subject device	Predicate device	Comparison	Impact toSafety &Effectiveness
Imagecommunication	Standard networkprotocols like TCP/IPand standardcommunicationprotocol DICOM.	Standard networkprotocols like TCP/IPand standardcommunicationprotocol DICOM.	Identical	NA
Imagingalgorithms	- Multiplanarreconstruction(MPR)- Maximum andMinimum IntensityProjection(MIP/MinIP)- Volume RenderingTechnique (VRT)with additionaledge and surfaceenhancements andcontrol overrenderingparameters- Shaded SurfaceDisplay (SSD)- DigitallyReconstructed- Radiograph- Editor functionality(e.g. ClipBox)- Registration- Anatomicalregistration- Region growing- Automatic SpineLabeling, also forribs in CT thoraxscans 1- Reprocessing X-ray projectionimages into 3Dimage andTopograms 15- FASTAlign	- Multiplanarreconstruction(MPR)- Maximum andMinimum IntensityProjection(MIP/MinIP)- Volume RenderingTechnique (VRT)with additionaledge and surfaceenhancements andcontrol overrenderingparameters- Shaded SurfaceDisplay (SSD)- DigitallyReconstructed- Radiograph- Editor functionality(e.g. ClipBox)- Registration- Anatomicalregistration- Region growing- Automatic SpineLabeling, also forribs in CT thoraxscans 2 (“Riblabeling”)- Reprocessing X-ray projectionimages into 3Dimage andTopograms 16	Similar:Algorithmsunderwentbug-fixing andminorimprovements. No re-training orchange inalgorithmmodels wasperformed.	The changesbetween thepredicate deviceand the subjectdevice doesn'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for thesafety andeffectiveness ofthe subjectdevice
Quantitativealgorithms	Distance, angle &angle-on-stack, VOI andROI measurements	Distance, angle, VOIand ROI measurements	Angle-Toolwas extendedwith Angle-	The changesbetween thepredicate deviceand the subject
	Subject device	Predicate device	Comparison	Impact toSafety &Effectiveness
			on-Stackfunctionality	device doesn'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for thesafety andeffectiveness ofthe subjectdevice
Supported ImageGeneratingModalities	The following Imagetypes are supported bysyngo.via View&GO:- CT Image(ComputedTomography)- MR Image(MagneticResonance)- NM Image(Nuclear Medicine)- XA Image (X-RayAngiography)- US Image(Ultrasound)- DX Image (DigitalRadiography)- DICOM secondarycapture objects	The following Imagetypes are supported bysyngo.via View&GO:- CT Image(ComputedTomography)- MR Image(MagneticResonance)- NM Image(Nuclear Medicine)- XA Image (X-RayAngiography)- US Image(Ultrasound)- DX Image (DigitalRadiography)- DICOM secondarycapture objects	Identical	NA
Image dataCompression	Receive & Store:Images are received andstored as receivedwithout any change inthe compression format.Display:Images are displayed asreceived without anychange in thecompression.Lossy compressionimages are displayedwith an indication to theuser with thecompression ratio.	Receive & Store:Images are received andstored as receivedwithout any change inthe compression format.Display:Images are displayed asreceived without anychange in thecompression.Lossy compressionimages are displayedwith an indication to theuser with thecompression ratio.	Identical	NA
	Subject device	Predicate device	Comparison	Impact toSafety &Effectiveness
	To DICOM Node:Images are sent as perthe DICOMnegotiation.Uncompressed ispreferred and lossycompression is notsupported.	To DICOM Node:Images are sent as perthe DICOMnegotiation.Uncompressed ispreferred and lossycompression is notsupported.
	To Exchangeablemedia: Images exportedas stored in the localstorage.	To Exchangeablemedia: Images exportedas stored in the localstorage.
	SupportedCompressions forexport: losslesscompressionalgorithms, JPEG,JPEG 2000 and RLE.	SupportedCompressions forexport: losslesscompressionalgorithms, JPEG,JPEG 2000 and RLE.
Operatingsystem	Workplace:Microsoft Windows 10- 64 bit or higherMicrosoft Windows 7 –64 bit SP1(for update only)	Workplace:Microsoft Windows 10- 64 bit or higherMicrosoft Windows 7 –64 bit SP1(for update only)	Identical	NA
Impact on ImageGeneratingDevices	None.syngo.via View&GO isa pure post processingsoftware and there is noinfluence on the imagegenerating devices	None.syngo.via View&GO isa pure post processingsoftware and there is noinfluence on the imagegenerating devices	NA as boththe devices donot impact theImagegeneratingdevices.	NA
CADFunctionalities	None.No automateddiagnosticinterpretationcapabilities like CADare included. All imagedata are to beinterpreted by trainedpersonnel.	None.No automateddiagnosticinterpretationcapabilities like CADare included. All imagedata are to beinterpreted by trainedpersonnel.	NA as boththe devicesdon't supportany CADfunctionalities.	NA
Software self-test / checks	Alert the user in casethe data transfer isinterrupted to theconnected DICOMnode.Hardware / Operatingsystem compatibilitycheck duringInstallation.	Alert the user in casethe data transfer isinterrupted to theconnected DICOMnode.Hardware / Operatingsystem compatibilitycheck duringInstallation.	Identical	NA
	Subject device	Predicate device	Comparison	Impact toSafety &Effectiveness
	Display CompatibilityCheck supports the enduser to qualify thesystem for properdiagnostic use.	Display CompatibilityCheck supports the enduser to qualify thesystem for properdiagnostic use.
Cyber Security	- User access control- Audit trails- Documentation of- system securityinformation,- Network traffic &- Firewall control- Support of virus /- malware protection.	- User access control- Audit trails- Documentation of- system securityinformation,- Network traffic &- Firewall control- Support of virus /- malware protection.	Identical	NA
Hardware	Hardware is notunderstood as part of themedical device butneeds to comply withthe minimumrequirements asspecified by syngo.viaView&GO.	Hardware is notunderstood as part ofthe medical device butneeds to comply withthe minimumrequirements asspecified by syngo.viaView&GO.	Identical	NA
Software Functionalities
Graphical UserInterface	Yes, with reducedcolor palette, clearerstructure and textlabels on icons.	Yes, with reduced colorpalette, clearer structureand text labels on icons	Similar - Thechanges arelimited to thecommon lookand feelbased onSiemensHealthineersUserInterfaceStyle Guide.	The changesbetween thepredicate deviceand the subjectdevice doesn'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for thesafety andeffectiveness ofthe subjectdevice.
Patient Browser	Yes, with simplifiedsearch functionality,clearer structure ofsearch results, imagepreview, unlimitedsearch results, periodicupdates of searchresults.	Yes, with simplifiedsearch functionality,clearer structure ofsearch results, imagepreview, unlimitedsearch results, periodicupdates of searchresults.	Identical	NA
	Subject device	Predicate device	Comparison	Impact toSafety &Effectiveness
Series navigator	The Series Navigatorlists all currentlyloaded data within aworkflow.	Yes, the SeriesNavigator lists allcurrently loaded datawithin a workflow.	Identical	NA
Findings /Reporting	No, reporting supportis provided to createreports using any 3rdparty reporting tool.Hence the findingsalso cannot benavigated.	No, reporting support isprovided to createreports using any 3rdparty reporting tool.Hence the findings alsocannot be navigated.	Identical	NA
Import andexport of data	Import of DICOM datafrom network nodes orexternal media, and ofDICOM-compliant ornon DICOM-compliant data fromexternal media andWindows file system.Export to USB,Windows file system,or other DICOMnodes.	Import of DICOM datafrom network nodes orexternal media, and ofDICOM-compliant ornon DICOM-compliant data fromexternal media andWindows file system.Export to USB,Windows file system,or other DICOMnodes.	Identical	NA
Archiving data	Data can be sent to anarchive if syngo.viaView&GO isconnected to a PACSor correspondingDICOM node.	Data can be sent to anarchive if syngo.viaView&GO isconnected to a PACSor correspondingDICOM node.	Identical	NA
Ranges	Yes, parallel, radial,Radial sliced, Curvedand Spine ranges aresupported.Additionally,Anatomical Rangepresets 3 can becreated.	Yes, parallel, radial,Radial sliced, Curvedand Spine ranges aresupported.Additionally,Anatomical Rangepresets 4 can becreated.	Spine Rangesand Rangepresets arealsosupported forMR imagesin the subjectdevice.	This differencebetween thepredicate deviceand the subjectdevice doesn'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for thesafety and
	Subject device	Predicate device	Comparison	Impact toSafety &Effectiveness
				effectiveness ofthe subjectdevice.
Spine/Riblabeling	Yes, with suggestedspine labels to beconfirmed by the user,and additional smartplacement of labels,also in inter-vertebraregions, support of 2Dimages, support ofmulti-series studies,and added support forrib labels.	Yes, with suggestedspine labels to beconfirmed by the user,and additional smartplacement of labels,also in inter-vertebraregions, support of 2Dimages, support ofmulti-series studies,and added support forrib labels.	The Spine /Rib labelingfunctionalitycan beinvokeddirectly fromCorner Menuinstead ofinvoking itvia Rangetool tofacilitatedirect accessfor the user.Theunderlyingalgorithm hasnot changedbeyond bugfixing.	The changesbetween thepredicate deviceand the subjectdevice doesn'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for thesafety andeffectiveness ofthe subjectdevice
Communication	Yes, Interface withDICOM is supported.	Yes, Interface withDICOM is supported.	Identical	NA
Printing	Yes, both paper andDICOM printingsupported.	Yes, both paper andDICOM printingsupported.	Identical	N/A
Online helpsystem	Yes, with reducedcolor palette, clearerstructure and textlabels on icons.	Yes, with reducedcolor palette, clearerstructure and textlabels on icons.	Identical	NA
Markers andannotations	Yes,- with support formarking a positionon an image andtextualannotations.	Yes,- with support formarking a positionon an image andtextualannotations.	Identical	NA