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

Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA40A. This 510(k) submission describes several modifications to the previously cleared predicate device. syngo.via View&GO, software version VA30A.

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.

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 VA40A, as well as the predicate device, syngo.via View&GO, software version VA30A.

AI/ML Overview

The provided text is a 510(k) summary for the syngo.via View&GO VA40A software, seeking substantial equivalence to a predicate device (syngo.via View&GO VA30A). While it details the device, its intended use, and comparisons to the predicate, it does not contain information about specific acceptance criteria or the details of a study proving the device meets those criteria.

The document states:

"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." (Page 14, Section 8)
"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." (Page 14, Section 9)
"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." (Page 14, Section 10)

However, it does not provide the specific "acceptance criteria" themselves, nor does it describe the details of the "study" (beyond mentioning "non-clinical tests" and "verification and validation testing") that would demonstrate performance against these criteria.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

A table of acceptance criteria and the reported device performance: The acceptance criteria are not explicitly listed, nor are the specific performance results against them. The document only generally states that "all software specifications have met the acceptance criteria."
Sample sizes used for the test set and the data provenance: No information on sample sizes or data provenance (country, retrospective/prospective) for the test set is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no specific study details are given, this information is not present.
Adjudication method for the test set: No information on adjudication is provided.
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: The document states the device is a "Medical Image Management and Processing System" and explicitly says "No automated diagnostic interpretation capabilities like CAD are included." (Page 9, CAD Functionalities table row). It is a post-processing and viewing software, not an AI/CAD system designed to directly improve human diagnostic performance via AI assistance. Therefore, an MRMC study for AI assistance would likely not be relevant or performed for this device category.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided information hints at functional and software verification/validation, which are forms of standalone testing, but no specific performance metrics are given.
The type of ground truth used: Not specified.
The sample size for the training set: The document implies this is not an AI/ML algorithm that requires a "training set" in the typical sense for clinical performance. The "Imaging algorithms" section (Page 7-8) mentions "bug-fixing and minor improvements" and "No re-training or change in algorithm models was performed," suggesting that existing, validated algorithms were refined.
How the ground truth for the training set was established: Not applicable, as detailed above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through software verification and validation, and functional performance tests, rather than a detailed clinical study with specific acceptance criteria and performance metrics typically seen for AI/ML diagnostic aids. The changes introduced in VA40A compared to VA30A are primarily related to software architecture, operating system support (Windows 11), minor algorithm bug fixes, and user interface improvements, and the inclusion of a "Cinematic VRT" algorithm that was previously cleared. The "Imaging algorithms" section explicitly states: "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 were taken for the safety and effectiveness of the subject device." This implies the focus was on ensuring the new version maintained the safety and effectiveness of the predicate, rather than proving a statistically significant improvement via a new clinical study.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Healthcare GmBH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K230196

February 13, 2023

Trade/Device Name: syngo.via View&GO VA40A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 24, 2023 Received: January 25, 2023

Dear Prithul Bom:

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

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) K230196

Device Name syngo.via View&GO VA40A

Indications for Use (Describe)

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.

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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section E: 510(k) Summary

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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: January 10, 2023

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 VA40A)
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 VA30A)
510(k) Clearance:	K221501
Clearance Date:	October 14, 2022
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
Recall Information:	This predicate device has not been the subject of anydesign related recalls.

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1. Additional Legally Marketed Reference Device

Trade Name:	Syngo Carbon Space VA20A
510(k) Clearance:	K213665
Clearance Date:	June 21, 2022
Classification Name:	Medical Image Management and Processing System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ
Recall Information:	This device has not been the subject of anydesign related recalls.

Device Description:

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

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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.

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.

6.3 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.

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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 VA40A to the predicate device syngo.via View&GO VA30A:

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¹ cinematic VRT as a functionality was already covered by a 510(k) clearance with the device syngo.Carbon Space, K213665

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Figure 1: Predicate Device Comparison Table

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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 14971:2019 Third Edition 2019-12 -
-EC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
IEC 82304-1 Edition 1.0 2016-10 -
-IEC 62366-1 Edition 1.1 2020-06 Consolidated Version
IEEE Std 3333.2.1-2015 -

9. 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 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.

10. Summarv:

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.

9. Safety and Effectiveness Information:

Software specifications, 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.

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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 V A40A, 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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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& Effectiveness
Device name andversion (Knumber)	syngo .via View&GO(Version VA40A)	syngo .via View&GOVersion VA30A(K221501)	New productversion	NA
Manufacturer	Siemens HealthcareGmbH	Siemens HealthcareGmbH	Identical	NA
Intended use	syngo .via View&GO is asoftware solution intendedto be used for viewing,manipulation,communication, andstorage of medicalimages.It can be used as a stand-alone device or togetherwith a variety of clearedand unmodified syngobased software options.syngo .via View&GOsupports interpretationand evaluation ofexaminations withinhealthcare institutions, forexample, in Radiology,Nuclear Medicine andCardiology environments.The system is notintended for thedisplaying of digitalmammography images fordiagnosis in the U.S.	syngo .via View&GO is asoftware solution intendedto be used for viewing,manipulation,communication, andstorage of medicalimages.It can be used as a stand-alone device or togetherwith a variety of clearedand unmodified syngobased software options.syngo .via View&GOsupports interpretationand evaluation ofexaminations withinhealthcare institutions, forexample, in Radiology,Nuclear Medicine andCardiology environments.The system is notintended for thedisplaying of digitalmammography images fordiagnosis in the U.S.	Identical	NA
Softwarearchitecture	Standalone workplacesystem that is logicallybroken down to syngo.viaView&GO subsystems.Subsystems are furtherbroken down to syngomodules.	Standalone workplacesystem that is logicallybroken down to syngo.viaView&GO subsystems.Subsystems are furtherbroken down to syngomodules.	Identical	NA
Imagecommunication	Standard networkprotocols like TCP/IP andstandard communicationprotocol DICOM.	Standard networkprotocols like TCP/IP andstandard communicationprotocol DICOM.	Identical	NA
Imagingalgorithms	-Multiplanarreconstruction (MPR)	-Multiplanarreconstruction (MPR)	Similar:Algorithms	The changesbetween the
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
	Maximum andMinimum IntensityProjection(MIP/MinIP)Volume RenderingTechnique (VRT)with additional edgeand surfaceenhancements andcontrol overrendering parametersShaded SurfaceDisplay (SSD)DigitallyReconstructedRadiographEditor functionality(e.g. ClipBox)Auto-ContourRegistrationAnatomicalregistrationRegion growingAutomatic SpineLabeling, also for ribsin CT thorax scans("Rib labeling")Reprocessing X-rayprojection imagesinto 3D image andTopogramsFASTAlignCinematic VRT1	Maximum andMinimum IntensityProjection(MIP/MinIP)Volume RenderingTechnique (VRT)with additional edgeand surfaceenhancements andcontrol overrendering parametersShaded SurfaceDisplay (SSD)DigitallyReconstructedRadiographEditor functionality(e.g. ClipBox)Auto-ContourRegistrationAnatomicalregistrationRegion growingAutomatic SpineLabeling, also for ribsin CT thorax scans("Rib labeling")Reprocessing X-rayprojection imagesinto 3D image andTopogramsFASTAlign	underwent bug-fixing andminorimprovements.No re-trainingor change inalgorithmmodels wasperformed.The cinematicVRT algorithmwas added, thatwas previouslycleared withK213665.	predicate deviceand the subjectdevice doesn'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for the safetyand effectivenessof the subjectdevice
Quantitativealgorithms	Distance, angle & angle-on-stack, VOI and ROImeasurements	Distance, angle & angle-on-stack, VOI and ROImeasurements	Identical	NA
Supported ImageGeneratingModalities	The following Image typesare supported by syngo.viaView&GO:CT Image (ComputedTomography)MR Image (MagneticResonance)NM Image (NuclearMedicine)XA Image (X-RayAngiography)US Image(Ultrasound)DX Image (DigitalRadiography)	The following Image typesare supported by syngo.viaView&GO:CT Image (ComputedTomography)MR Image (MagneticResonance)NM Image (NuclearMedicine)XA Image (X-RayAngiography)US Image(Ultrasound)DX Image (DigitalRadiography)	Identical	NA
	Subject device	Predicate device	Comparison	Impact to Safety & Effectiveness
	DICOM secondary capture objects	DICOM secondary capture objects
Image data Compression	Receive & Store:Images are received and stored as received without any change in the compression format.Display:Images are displayed as received without any change in the compression.Lossy compression images are displayed with an indication to the user with the compression ratio.Export:To DICOM Node: Images are sent as per the DICOM negotiation. Uncompressed is preferred and lossy compression is not supported.To Exchangeable media: Images exported as stored in the local storage.Supported Compressions for export: lossless compression algorithms, JPEG, JPEG 2000 and RLE.	Receive & Store:Images are received and stored as received without any change in the compression format.Display:Images are displayed as received without any change in the compression.Lossy compression images are displayed with an indication to the user with the compression ratio.Export:To DICOM Node: Images are sent as per the DICOM negotiation. Uncompressed is preferred and lossy compression is not supported.To Exchangeable media: Images exported as stored in the local storage.Supported Compressions for export: lossless compression algorithms, JPEG, JPEG 2000 and RLE.	Identical	NA
Operating system	Workplace:Microsoft Windows 11-64 bit or higherMicrosoft Windows 10 - 64 bit or higher	Workplace:Microsoft Windows 10 - 64 bit or higherMicrosoft Windows 7 - 64 bit SP1(for update only)	Windows 11 support included.Windows 7 support was removed	The changes between the predicate device and the subject device don't impact the safety and effectiveness of the subject device as the necessary measures were taken for the safety and effectiveness of the subject device
	Subject device	Predicate device	Comparison	Impact to Safety& Effectiveness
Impact on ImageGeneratingDevices	None.syngo.via View&GO is apure post processingsoftware and there is noinfluence on the imagegenerating devices	None.syngo.via View&GO is apure post processingsoftware and there is noinfluence on the imagegenerating devices	NA as both thedevices do notimpact theImagegeneratingdevices.	NA
CADFunctionalities	None.No automated diagnosticinterpretation capabilitieslike CAD are included.All image data are to beinterpreted by trainedpersonnel.	None.No automated diagnosticinterpretation capabilitieslike CAD are included.All image data are to beinterpreted by trainedpersonnel.	NA as both thedevices don'tsupport anyCADfunctionalities.	NA
Software self-test/ checks	Alert the user in case thedata transfer isinterrupted to theconnected DICOM node.Hardware / Operatingsystem compatibilitycheck during Installation.Display CompatibilityCheck supports the enduser to qualify the systemfor proper diagnostic use.	Alert the user in case thedata transfer isinterrupted to theconnected DICOM node.Hardware / Operatingsystem compatibilitycheck during Installation.Display CompatibilityCheck supports the enduser to qualify the systemfor proper diagnostic use.	Identical	NA
Cyber Security	- User access control- Audit trails- Documentation ofsystem securityinformation, Networktraffic & Firewallcontrol- Support of virus /malware protection.	- User access control- Audit trails- Documentation ofsystem securityinformation, Networktraffic & Firewallcontrol- Support of virus /malware protection.	Identical	NA
Hardware	Hardware is notunderstood as part of themedical device but needsto comply with theminimum requirements asspecified by syngo.viaView&GO.	Hardware is notunderstood as part of themedical device but needsto comply with theminimum requirements asspecified by syngo.viaView&GO.	Identical	NA
Software
	Subject device	Predicate device	Comparison	Impact to Safety& Effectiveness
Graphical UserInterface	Yes, with reduced colorpalette, clearer structureand text labels on icons.	Yes, with reduced colorpalette, clearer structureand text labels on icons	Identical	NA
Patient Browser	Yes, with simplifiedsearch functionality,clearer structure ofsearch results, imagepreview, unlimitedsearch results, periodicupdates of search results.	Yes, with simplifiedsearch functionality,clearer structure of searchresults, image preview,unlimited search results,periodic updates of searchresults.	Identical	NA
Series navigator	The Series Navigatorlists all currently loadeddata within a workflow.Studies are marked withcolorized timepoints.	Yes, the Series Navigatorlists all currently loadeddata within a workflow.Studies are marked as"prior" and "current"according to theiracquisition date.	To improve thevisualizationof studiesaccording totheir differenttimepoints ofacquisition, thetimepoints areshown in datesof differentcolors and thestudy date isfeatured moreprominentlywith larger andbold font in thesubject device.	The changesbetween thepredicate deviceand the subjectdevice don'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for the safetyand effectivenessof the subjectdevice. Thefunctionality waspreviously clearedwith additionalreference deviceK213665.
Findings /Reporting	No, reporting support isprovided to create reportsusing any 3rd partyreporting tool. Hence thefindings also cannot benavigated.	No, reporting support isprovided to create reportsusing any 3rd partyreporting tool. Hence thefindings also cannot benavigated.	Identical	NA
Import and exportof data	Import of DICOM datafrom network nodes orexternal media, and ofDICOM-compliant ornon DICOM-compliantdata from external mediaand Windows filesystem.Export to USB, Windowsfile system, or otherDICOM nodes.	Import of DICOM datafrom network nodes orexternal media, and ofDICOM-compliant ornon DICOM-compliantdata from external mediaand Windows filesystem.Export to USB, Windowsfile system, or otherDICOM nodes.	Identical	NA
Archiving data	Data can be sent to anarchive if syngo.via	Data can be sent to anarchive if syngo.via	Identical	NA
	Subject device	Predicate device	Comparison	Impact to Safety& Effectiveness
	View&GO is connectedto a PACS orcorresponding DICOMnode.	View&GO is connectedto a PACS orcorresponding DICOMnode.
Ranges	Yes, parallel, radial,Radial sliced, Curvedand Spine ranges aresupported. Additionally,Anatomical Rangepresets can be created.	Yes, parallel, radial,Radial sliced, Curvedand Spine ranges aresupported. Additionally,Anatomical Rangepresets can be created.	identical	NA
Spine/Rib labeling	Yes, with suggestedspine labels to beconfirmed by the user,and additional smartplacement of labels, alsoin inter-vertebra regions,support of 2D images,support of multi-seriesstudies, and addedsupport for rib labels.	Yes, with suggestedspine labels to beconfirmed by the user,and additional smartplacement of labels, alsoin inter-vertebra regions,support of 2D images,support of multi-seriesstudies, and addedsupport for rib labels.	Identical.	NA
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 reduced colorpalette, clearer structureand text labels on icons.	Yes, with reduced colorpalette, clearer structureand text labels on icons.	Identical	NA
Markers andannotations	Yes,- with support formarking a positionon an image andtextual annotations.	Yes,- with support formarking a positionon an image andtextual annotations.	Similar:AutoContourand PolygonalROI areaccessed bythe user in adifferentmanner in thesubject device.No functionalchanges/improvements wereimplementedwith respect tothe predicatedevice.	The changesbetween thepredicate deviceand the subjectdevice don'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for the safetyand effectivenessof the subjectdevice.
Hiding andShowing of ImageOverlays	- show or hide imagetext- show or hide customimage text	- show or hide imagetext- show or hide customimage text	Shutter-Toolwas added to	The changesbetween thepredicate device
Subject device	Predicate device	Comparison	Impact to Safety& Effectiveness
- show or hidegraphical objectssuch as annotationsand markers- show or hidereference lines- show or hideshutters	- show or hidegraphical objectssuch as annotationsand markers- show or hidereference lines	the subjectdevice.	and the subjectdevice don'timpact the safetyand effectivenessof the subjectdevice as thenecessarymeasures weretaken for the safetyand effectivenessof the subjectdevice. Thefunctionality waspreviously clearedwith additionalreference deviceK213665.