syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.

syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

Device Description

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations. syngo Dynamics provides various semi-automated anatomical visualization tools.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting; A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device: syngo Dynamics (Version VA40F) - Specifically, the Auto EF algorithm.

Acceptance Criteria (for Auto EF)	Reported Device Performance (Auto EF)
Pearson's correlation coefficient r ≥ 0.800 between Auto EF biplane EF and ground truth	Biplane EF correlation was 0.827 between Auto EF and ground truth (P<0.0001)
Total of 12 predetermined acceptance criteria (specific criteria not detailed in the provided text)	Auto EF results exceeded all 12 defined acceptance criteria.

2. Sample Size and Data Provenance

Test Set Sample Size: n = 150 cases.
Data Provenance:
- Country of Origin: U.S. (3 sites with geographic diversity from 2 different regions).
- Retrospective/Prospective: Not explicitly stated, but the description "independent of the training data" and "representative of the intended use population" suggests it's likely retrospective data used for independent validation.

3. Number of Experts and Their Qualifications for Ground Truth

Number of Experts: 2 experienced sonographers.
Qualifications: "experienced sonographers". No specific years of experience or board certifications are mentioned.

4. Adjudication Method for the Test Set

The ground truth was established by two sonographers who "worked independently of each other and did not have access to Auto EF when establishing the ground truth." This implies that the initial ground truth was established independently. The text does not explicitly state if there was an adjudication method (e.g., 2+1, 3+1) if their measurements differed, or whether a consensus process was applied. It simply states they "worked independently."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted to assess how much human readers improve with AI vs. without AI assistance. The study focused on the standalone performance of the Auto EF algorithm against a ground truth established by human experts.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted for the Auto EF algorithm. The text states: "standalone performance testing for Auto EF was conducted to assess the performance of Auto EF compared to the ground truth (reference standard) established using conventional methods."

7. Type of Ground Truth Used

The ground truth for the Auto EF test set was established by expert consensus using a conventional manual method for Left Ventricular (LV) volumes and Ejection Fraction (EF). Specifically, the "Method of Disks" (MOD), also known as the Modified Simpson's Rule, was used by two experienced sonographers working independently.

8. Sample Size for the Training Set

The sample size for the training set is not provided in the given text. It only states that the test data (n=150) are "independent of the training data used for the training of the Auto EF algorithm."

9. How the Ground Truth for the Training Set Was Established

The method for establishing the ground truth for the training set is not explicitly stated in the provided text. It only mentions that the test data was independent of the training data.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Siemens Medical Solutions USA, Inc. % Jiayan Liu Regulatory Affairs Manager 400 W. Morgan Road ANN ARBOR MI 48108

Re: K222428

November 14, 2022

Trade/Device Name: syngo Dynamics (Version VA40F) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: September 29, 2022 Received: October 4, 2022

Dear Jiayan Liu:

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/cfpmp/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 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

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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 medical devices and radiation-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)

K222428

Device Name syngo Dynamics (version VA40F)

Indications for Use (Describe)

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

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

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K222428

510(k) Summary

syngo Dynamics (Version VA40F)

In accordance with 21 CFR §807.92, the following summary of safety and effectiveness is provided.

SUBMITTER I.

21CFR § 807.92(a)(1)

Siemens Medical Solutions USA, Inc. 400 W. Morgan Road Ann Arbor, MI 48108

Contact Person: Jiayan Liu

Phone: +1 (734) 604-7870 Email: jiayan.liu@siemens-healthineers.com

Date Prepared: November 7, 2022

DEVICE II.

21CFR § 807.92(a)(2)

Device Trade Name	syngo Dynamics (version VA40F)
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Classification Panel	Radiology
Regulation Number	21 CFR §892.2050
Product Code	QIH

III. LEGALLY MARKETED PREDICATE DEVICES

21CFR § 807.92(a)(3)

Predicate Device
Device Trade Name	syngo Dynamics (Version VA40E)
510(k) Number	K220832
Product Code	LLZ

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION SUMMARY

21CFR § 807.92(a)(4)

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This premarket notification addresses the Siemens Healthineers syngo Dynamics (Version VA40F) Medical Image Management and Processing System (MIMPS).

In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

v. INTENDED USE/INDICATIONS FOR USE

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

Indications for Use Comparison

21CFR § 807.92(a)(5)

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Subject Devicesyngo Dynamics VA40F	Predicate Devicesyngo Dynamics VA40EK220832
syngo Dynamics is a multimodality, vendoragnostic Cardiology image and informationsystem intended for medical image managementand processing that provides capabilities relatingto the review and digital processing of medicalimages.	syngo Dynamics is a multimodality, vendoragnostic Cardiology image and informationsystem intended for medical image managementand processing that provides capabilities relatingto the review and digital processing of medicalimages.
syngo Dynamics supports clinicians by providingpost image processing functions for imagemanipulation, and/or quantification that areintended for use in the interpretation and analysisof medical images for disease detection,diagnosis, and/or patient management within thehealthcare institution's network.	syngo Dynamics supports clinicians by providingpost image processing functions for imagemanipulation, and/or quantification that areintended for use in the interpretation and analysisof medical images for disease detection,diagnosis, and/or patient management within thehealthcare institution's network.
syngo Dynamics is not intended to be used fordisplay or diagnosis of digital mammographyimages in the U.S.	syngo Dynamics is not intended to be used fordisplaying of digital mammography images fordiagnosis in the U.S.

The subject device, syngo Dynamics (Version VA40F) is a new version of the predicate device, syngo Dynamics VA40E (K220832). The Indications for Use for the subject device and the predicate device are identical. There were no fundamental changes to the device as a cardiology-focused information and imaging management software.

Neither the subject nor the predicate device is indicated for any specific disease, condition, or patient population, and both are intended to support healthcare professionals in the healthcare institutions' environment.

Both the subject and predicate devices share contraindication that they are not intended to be used for display or diagnosis of digital mammography images in the U.S.

Indications for Use/Intended Use Comparison Summary and Conclusion

The Indications for Use were assessed in accordance with the following FDA Guidance Documents:

. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Food and Drug Administration Staff Guidance for Industry, General/Specific Intended Use

The results of this evaluation determined that the Indications for Use for the subject device and the predicate device are fundamentally the same, and only includes minor updates. As such, Siemens Healthineers is of the opinion that the Intended Use and Indications for Use are similar to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

21CFR § 807.92(a)(6)

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Image /page/8/Picture/0 description: The image contains the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

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Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

The functionalities of subject and predicate devices are fundamentally the same except for differences in image review features. Comparing with the predicate, the subject device is supplied with AVML algorithm that enable an optional semi-automated method (Auto EF) to calculate left ventricle ejection fraction using ultrasound images. Both subject and predicate devices have identical manual calculations

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of left ventricular ejection fraction (LV EF). The subject device has an additional capability for semiautomated calculation of LV EF on images selected by the user and under full control of the user including possible manual intervention, performing equivalently to the manual measurement with no new concerns for the safety and effectiveness.

VII. PERFORMANCE DATA

The following performance data were provided in support to demonstarte similarities to the predicate /previously cleared device.

Clinical Testing

No clinical studies were carried out for syngo Dynamics (Version VA40F). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.

Summary of Non-Clinical Testing

No performance standards for MIMPS have been issued under the authority of Section 514. Nonclinical testing was conducted for the device syngo Dynamics (Version VA40F) during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthineers claims conformance to the following recognized consensus standards:

NEMA PS 3.1 3.20 (2016) ●
ISO IEC 10918-1 First edition 1994-02-15 ●
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION ●
ISO 14971 Third Edition 2019-12
IEEE Std 3333.2.1-2015
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
IEC TR 80001-2-2 Edition 1.0 2012-07 ●
IEC 82304-1 Edition 1.0 2016-10 .

Software Verification and Validation

In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.

Cybersecurity considerations related to syngo Dynamics are included within this submission. Siemens Healthineers conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

Risk Analysis, in compliance with ISO 14971 Third Edition, for syngo Dynamics (Version VA40F) 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

21CFR § 807.92(b)(2)

21CFR § 807.92(b)(1)

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validation for the device was found acceptable in support to determine similarities to the predicate /previously cleared device.

Validation Studies for AI/ML-enabled functions

Auto EF

To validate the syngo Dynamics (Version VA40F) Intended Use, standalone performance testing for Auto EF was conducted to assess the performance of Auto EF compared to the ground truth (reference standard) established using conventional methods.

The test data (n = 150) represent 3 sites in the U.S. with geographic diversity from 2 different regions and are independent of the training data used for the training of the Auto EF algorithm. The test data are representative of the intended use population for Auto EF. They are balanced for gender and cover an age range from 21 to 93 years (average 64 years). The BMI ranges from 16.5 to 48.8 with an average of 27.9. Three ultrasound manufacturers (Philips, GE and Siemens) are included in the testing. Cases across the range of cardiac function are included.

The ground truth was established by 2 experienced sonographers using a conventional manual method to establish left ventriular volumes and ejection fraction with the "Method of Disks" (MOD) also known as the Modified Simpson's Rule. The 2 sonographers worked independently of each other and did not have access to Auto EF when establishing the ground truth.

Acceptance of the statistical data is a Pearson's correlation coefficient r ≥ 0.800 between the biplane EF generated by Auto EF and the ground truth. This acceptance criterion has been previously used for the purpose of evaluating left ventricular ejection fraction in FDA cleared products (K210053). Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria.

The Auto EF results are exceeding all 12 defined acceptance criteria. Biplane EF correlation was 0.827 between Auto EF and ground truth (P<0.0001).

The results of clinical data-based software validation for the subject device demonstrated equivalent performance in comparison to the reference generated using conventional manual analysis.

VIII. CONCLUSIONS

Performance tests were conducted to test the functionality of the device syngo Dynamics (Version VA40F). These tests have been performed to assess the functionality of the subject device. Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device.

Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.

The device does not come in contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.

Siemens Healthineers believes that syngo Dynamics (Version VA40F) is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.

21CFR § 807.92(b)(3)

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Substantial Equivalence Conclusion

The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo Dynamics is safe, effective and performs as well as the predicate device.

In summary, Siemens Healthineers is of the opinion that syngo Dynamics (Version VA40F) does not introduce any new significant potential safety risks and is similar to 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).

Attribute	Subject Devicesyngo Dynamics VA40F	Predicate Devicesyngo Dynamics VA40EK220832	EquivalencyAnalysis
Architecture	Client-server	Client-server	Identical
Supportedmodalities	US XA DX CT MR SC NM PT	US XA DX CT MR SC NM PT	Identical
Supporteddeployment	Standalone medical device including a DICOM Server Integrated model within an Electronic Health Record (EHR) System with a DICOM Archive Multimodality Cardiovascular (MMCV) deployment with native support of 2D/3D CT/MR image types	Standalone medical device including a DICOM Server Integrated model within an Electronic Health Record (EHR) System with a DICOM Archive Multimodality Cardiovascular (MMCV) deployment with native support of 2D/3D CT/MR image types	Identical
ImageCommunication	Within the network, the following communication protocols are used:TCP/IP: for communication and transport DICOM and HL7 at application level HTTP for communication and transport of images, MP4s and thumbnails	Within the network, the following communication protocols are used:TCP/IP for communication and transport DICOM and HL7 at application level HTTP(S) for communication and transport of images, MP4s and thumbnails	Identical
Image DataCompression	Lossless compression with compression factor 2 to 3 and lossy compression (JPEG and MP4) with higher compression rate	Lossless compression with compression factor 2 to 3 and lossy compression (JPEG and MP4) with higher compression rate	Identical
Attribute	Subject Devicesyngo Dynamics VA40F	Predicate Devicesyngo Dynamics VA40EK220832	EquivalencyAnalysis
ImagingAlgorithms	Window/Leveling Edge Enhancement Digital Subtraction Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT) Gamma Correction Manual and semi-automated calculation for left ventricular ejection fraction (Auto EF)	Window/Leveling Edge Enhancement Digital Subtraction Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT) Gamma Correction Manual calculation for left ventricular ejection fraction	Updated byadding semi-automatedejectionfraction
Quantitativealgorithms	Pixel Size Evaluation Distance line Angle volume	Pixel Size Evaluation Distance line Angle Volume	Identical
DecisionSupport	Ability to interface with a third-party rules engine (BizTalk),where rules are configured bythe end customer to determineclinical relevance of selectedobservations.Customers identify and storeselected patient data.Orchestrations provide a triggerto pull in previously storedrelevant data for a given study.	Ability to interface with a third-party rules engine (BizTalk),where rules are configured bythe end customer to determineclinical relevance of selectedobservations.Customers identify and storeselected patient data.Orchestrations provide a triggerto pull in previously storedrelevant data for a given study.	Identical
Reporting	Customizable DICOM Structured Reporting Collaborative reporting Web reporting	Customizable DICOM Structured Reporting Collaborative reporting Remote reporting	Identical
Attribute	Subject Devicesyngo Dynamics VA40F	Predicate Devicesyngo Dynamics VA40EK220832	EquivalencyAnalysis
Accessstrategies forimaging andreporting	Workplace (thick client)-access for reading andreporting.Remote Workplace (MP4image display with accessto full DICOM image forUS/XA and full DICOMimage for CT/MR) - accessfor reading and reportingWebViewer – (Web Clientwith MP4 Image display) -Access for review onlyPortal – (Web Client forreading and reporting withlimited functionality.)	Workplace (thick client) –access for reading andreporting.Remote Workplace (MP4image display with accessto full DICOM image forUS/XA and full DICOMimage for CT/MR) – accessfor reading and reporting.WebViewer- (Web Clientwith MP4 Image display) -Access for review only	Similar.Additionalportal accessfor review andlimitedfunctionalityin subjectdevice.
Mobile DeviceSupport	Yes –Through the CommonLogin and Portal ImageReview, images can be viewedon mobile devices, WebViewer,supports iOS and Androiddevices, but are non-diagnosticuse.	Yes - Through WebViewer,Supports iOS and Androiddevices, but non-diagnostic use.	Similar.Additionalportal accessfor review andlimitedfunctionalityin subjectdevice.
Long TermArchive	Provide long term archive andretrieve of DICOM studiesto/from either VNA (VendorNeutral Archive) or HSM(Hierarchical StorageManagement) archivingSystems.	Provide long term archive andretrieve of DICOM studiesto/from either VNA (VendorNeutral Archive) or HSM(Hierarchical StorageManagement) archivingSystems.	Identical
Hardware	Software-only option for serverWorkstation: software only(HW is not part of the medicaldevice, but needs to meetrecommended requirements asspecified by syngo Dynamics)	Software-only option for serverWorkstation: software only(HW is not part of the medicaldevice, but needs to meetrecommended requirements asspecified by syngo Dynamics)	Identical
Virtualization	Provides virtualization of serverand client machines	Provides virtualization of serverand client machines	Identical
Attribute	Subject Devicesyngo Dynamics VA40F	Predicate Devicesyngo Dynamics VA40EK220832	EquivalencyAnalysis
Operatingsystem	Server:Microsoft Windows server 2016Standard edition (64bit)Microsoft Windows Server2019 Standard Edition (64Bit)Client Software: MicrosoftWindows 10 x64 version1803 or greaterPortal Website Host:Microsoft Windows Server2016 Standard edition (64-bit),Microsoft Windows Server2019 Standard edition (64-bit)Server:Windows 2012 R2 ServerStandard Edition R2 (64-bit)Portal Client:Windows 7 SP1 or higher (64-bit)Portal Website Host:Windows 2012 R2 ServerStandard Edition R2 (64-bit)	Server:Microsoft Windows server 2016Standard edition (64bit)Microsoft Windows Server2019 Standard Edition (64Bit)Client Software: MicrosoftWindows 10 x64 version1803 or greaterPortal Website Host:Microsoft Windows Server2016 Standard edition (64-bit),Microsoft Windows Server2019 Standard edition (64-bit)Server: Windows 2012 R2Server Standard Edition R2 (64-bit)Portal Client:Windows 7 SP1 or higher (64-bit)Portal Website Host: Windows2012 R2 Server StandardEdition R2 (64-bit)	Identical
Deploymentstrategy	The use of syngo Dynamics VA30 server/workplace in the context of cardiovascular configuration. EHR/EHS Integrated configuration with syngo Dynamics server. Multi-modality cardiovascular configuration with native/syngo server and syngo Dynamics workplace with native/syngo components.	The use of syngo Dynamics VA40E server/workplace in the context of cardiovascular configuration. EHR/EHS Integrated configuration with syngo Dynamics server. Multi-modality cardiovascular configuration with native/syngo server and syngo Dynamics workplace with native/syngo components.	Identical