The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diaming and treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.

Device Description

The "syngo Application Software" (VE2) is medical diagnostic software for realviewing. diagnostic review. image manipulation. optimization. time communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VE2) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems.

Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the three new optional software features: 1) syngo DynaCT Sine Spin; 2).syngo DynaCT Multiphase; and 3) syngo Embolization Guidance. These new features will be added to the existing "syngo Application Software" (VD20) which was cleared in K173611 on 16/03/2018. These new software features are the subjects of this submission.

The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems. The "syngo Application Software" (VE2) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System remains the same.

AI/ML Overview

The document describes the Siemens "syngo Application Software" (VE2) and its new optional software features: syngo DynaCT Sine Spin, syngo DynaCT Multiphase, and syngo Embolization Guidance. The submission aims to demonstrate substantial equivalence to the predicate device, "syngo Application Software" (VD20) (K173611).

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

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a specific table with distinct "acceptance criteria" against which quantitative "reported device performance" is measured in a typical clinical trial format (e.g., Sensitivity X, Specificity Y). Instead, the acceptance is based on demonstrating that the new features are as safe and effective as the predicate device. The performance is reported through the results of bench testing and software validation, confirming the functionality and safety of the new features.

The core acceptance criterion is implicit: The new features ("syngo DynaCT Sine Spin", "syngo DynaCT Multiphase", and "syngo Embolization Guidance") must perform as intended, produce equivalent or improved image quality/functionality compared to the predicate, and not introduce any new issues of safety or effectiveness.

Feature Tested	Acceptance Criterion (Implicit)	Reported Device Performance
syngo DynaCT Sine Spin	Must provide better data coverage resulting in less cone beam artifacts compared to the predicate's syngo DynaCT, while maintaining the same reconstruction method and not introducing new safety/effectiveness issues.	"Bench test were conducted and were found acceptable and did not raise any new issues of safety or effectiveness. All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use." Specific tests included: Homogeneity of reconstructed image, Spatial Resolution, Contrast to Noise Ratio, Geometric Distortion, Radiation Metrics CTDI, DAP, Artifact analysis, Gantry positioning accuracy, z-direction Resolution (Reconstructed section thickness).
syngo DynaCT Multiphase	Must successfully depict 10 different time points within 60 seconds (compared to a single spin or four for cardiac imaging in the predicate), maintain the same reconstruction method, and not cause a reduction in image quality, nor introduce new safety/effectiveness issues.	"Bench test were conducted and were found acceptable and did not raise any new issues of safety or effectiveness. All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use." A phantom study was performed "to exclude a potential reduction in image quality over 10 runs." Specific tests included: Homogeneity of reconstructed image, Spatial Resolution, Contrast to Noise Ratio, Geometric Distortion, Radiation Metrics CTDI, DAP, Artifact analysis, Gantry positioning accuracy, z-direction Resolution (Reconstructed section thickness).
syngo Embolization Guidance	The modified feature, allowing user-defined proximal points, must increase applicability while the calculation method and algorithm remain unchanged and perform effectively in feeder vessel detection. It should not introduce new safety/effectiveness issues.	"Bench test were conducted and were found acceptable and did not raise any new issues of safety or effectiveness. All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use." The feeder detection algorithm was "validated in a study of randomly selected clinical cases with the result that it is additionally suitable for prostate arteries."
Overall Software Quality	Conformance to standards (ISO 14971, IEC 82304-1, IEC 62304, IEC 62366-1, IEC 80001-1), appropriate software verification and validation for a Moderate Level of Concern, successful risk analysis and mitigation, validated usability, and cybersecurity measures.	"All testable requirements... have been successfully verified and traced... The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans." "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." "The Human Factor Usability Validation showed no safety relevant functions that need to be validated with a summative usability validation." "Siemens conforms to the cybersecurity requirements."

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

The primary testing presented involves bench testing and phantom studies. For the "syngo Embolization Guidance" a "study of randomly selected clinical cases" was performed, but the sample size is not specified. The document does not provide details on data provenance (country of origin) or whether the clinical cases were retrospective or prospective. It appears that the clinical case study for Embolization Guidance was not the primary means of validation for this 510(k), as it focuses on demonstrating safety and effectiveness mainly through non-clinical methods.

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

The document does not specify the number or qualifications of experts used to establish ground truth for any part of the test set. For the "syngo Embolization Guidance" clinical case study, it states the algorithm was "validated," implying comparison to some form of truth, but details are absent. For bench and phantom tests, ground truth would naturally be established by the physical properties of the phantoms/test setups.

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

The document does not describe any adjudication method for the test set. Given the nature of the validation (bench testing, phantom studies, and an unspecified clinical case study), a formal multi-reader adjudication process for establishing ground truth is not explicitly mentioned or implied.

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 MRMC comparative effectiveness study is described in the provided text. The submission focuses on demonstrating substantial equivalence of the software features themselves, not on the improvement of human reader performance with AI assistance. The device is a "Picture Archiving and Communications System" with features to assist physicians in image viewing and post-processing, not an AI diagnostic aid that directly impacts human reader interpretation.

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

Yes, the testing primarily focuses on the standalone performance of the algorithms and software features themselves through bench tests and phantom studies. For example, the image quality metrics (homogeneity, spatial resolution, CNR, etc.) are objective measures of the algorithm's output. The validation of the "syngo Embolization Guidance" feeder detection algorithm is also an assessment of its standalone accuracy, even if comparing against clinical cases.

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

For syngo DynaCT Sine Spin and syngo DynaCT Multiphase: Ground truth for image quality and physical properties (e.g., homogeneity, spatial resolution, CNR, geometric distortion, z-direction resolution) would be established by the known physical properties of the phantoms and the design specifications of the system.
For syngo Embolization Guidance: The feeder detection algorithm was "validated in a study of randomly selected clinical cases." This implies comparison to clinical ground truth, which for feeder vessels is typically established through expert review of angiographic images or potentially confirmed by intervention outcomes, though the document does not specify the exact nature of this clinical ground truth.

8. The sample size for the training set

The document does not mention a training set size. This might be because the changes are primarily functional enhancements to existing software features rather than completely new AI algorithms that require extensive training data. It states the "algorithm was not changed" for syngo Embolization Guidance, implying it was pre-existing.

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

Since no training set is explicitly mentioned or described, the method for establishing its ground truth is not provided.

Summary

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Siemens Medical Solution USA, Inc. % Ms. Patricia D. Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K190780

Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 9, 2019 Received: August 13, 2019

Dear Ms. Jones:

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

September 12, 2019

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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,

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190780

Device Name

syngo Application Software

Indications for Use (Describe)

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.

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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CONTINUE ON A SEPARATE PAGE IF NEEDED.
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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)
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510(k) Summary: "syngo Application Software"

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355

Date Prepared: September 11, 2019

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Email: patricia.d.iones@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: Classification Name:

Classification Panel: Classification Regulation: Device Class: Product Code:

syngo Application Software Picture Archiving and Communications System Radiology 21 CFR §892. 2050 Class II LLZ

1. Legally Marketed Predicate Device Trade Name: syngo Application Software

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510(k) Clearance Clearance Date Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code: Recall Information:

K173611 03/16/2018 Picture Archiving and Communications System Radiology 21 CFR §892. 2050 Class II LLZ This predicate device has not been the subject of any design related recalls.

5. Device Description:

Siemens "syngo Application Software" (VE2) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems.

6. Indications for Use:

The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

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The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed includes minimally invasive surgical procedures and minimally invasive tumor treatment.

Summary of Technological Characteristics of the Subject Device as 7. Compared with the Predicate Device:

The subject device has the same intended use as the predicate device. Besides the proposed device modifications, the Subject Device has the same functionality and technology. Therefore the subject device is considered substantially equivalent to the commercially available Siemens' "syngo Application Software" (VD20).

All software components of the subject device are the same as the ones from the predicate device except for the new optional software applications as presented in the table below:

The table below provides comparison of the Subject Device modifications to the Predicate Device.

Modification	Subject Devicesyngo Application Software VE2	Predicate Device syngo ApplicationSoftware VD20 (K173611)
syngoDynaCTsyngo SineSpin	This is a new feature with a sphericalspiral trajectory with an additionalsinusoidal movement component inCran/Caud direction. The 3D trajectorystarts with a Cran/Caud angle of zero.then goes to an angle of e.g. ten degreesin Cran direction, goes back to zero inthe middle of the trajectory, then goes to	syngo DynaCT is an imaging softwareused to obtain CT like images. It allowsthe reconstruction of three-dimensionalvolume data (consisting of tomographicslices) out of two-dimensional projectionimages acquired with a standardangiographic C-arm device. It is alsoused for imaging both high contrast
Modification	Subject Device	Predicate Device syngo ApplicationSoftware VD20 (K173611)
	syngo Application Software VE2
	ten degrees in Caud direction and backto Cran/Caud zero at the end of thetrajectory. This allows better datacoverage resulting less cone beamartifacts.	objects (vessels with iodine, bone) andsoft tissue as well as other internal bodystructures for diagnosis, surgicalplanning, interventional procedures andtreatment follow-up.
Comparison& Results	Comparison: The differences between the syngo DynaCT Sine Spin and syngoDynaCT is that the predicate device software feature does not have spherical spiraltrajectory, which is an additional sinusoidal movement component in Cran/Cauddirection. The reconstruction method is the same.
	Results: Bench test were conducted and were found acceptable and did not raiseany new issues of safety or effectiveness. All software validation data demonstratesthat the Subject Device is as safe and effective when compared to the PredicateDevice that is currently marketed for the same intended use.
syngoDynaCTMultiphase	syngo DynaCT Multiphase can be usedto assess the collateral status with timeresolved DynaCT, depicting 10 differenttime points within a period of 60 seconds.	syngo DynaCT uses a single spin toderive CT-like images. syngo DynaCTCardiac with ECG triggering uses fourconsecutive DynaCT runs to optimizethe image quality for cardiac imaging.
Comparison& Results	Comparison: The differences between the syngo DynaCT Multiphase and syngoDynaCT (cardiac) is that the predicate device allows two runs (typically one maskand one fill run) - four for DynaCT cardiac -The Subject Device feature allows tenconsecutive runs which results in depicting 10 different time points within a period of60 seconds. The reconstruction method is the same
	Results: Bench test were conducted and were found acceptable and did not raiseany new issues of safety or effectiveness. All software validation data demonstratesthat the Subject Device is as safe and effective when compared to the PredicateDevice that is currently marketed for the same intended use.
syngoEmbolizationGuidance	The modified syngo EmbolizationGuidance in software VE2 allows theproximal point to be set by user, thusreducing automation, but increasing theapplicability of syngo EmbolizationGuidance. The calculation method itselfremains as in the predicate device. Thealgorithm was not changed.	syngo Embolization Guidance wasintroduced to determine automaticallythe feeder vessel for specific hepaticlesions, e.g. a tumor. Part of thisautomation relied on an automaticdetection of the proximal point for thealgorithm to know where to start thesearch for the feeder vessels.
Comparison& Results	Comparison: The differences between the modified syngo Embolization GuidanceVE2 and the Predicate Device syngo Embolization Guidance is the modified versionthat allows the proximal point to be set by the user, thus reducing automation, butincreasing the applicability of the feature. The Subject Device automatically detectsthe feeder vessel for specific hepatic lesions, e.g. a tumor. Part of this automationrelied on an automatic detection of the proximal point for the algorithm to knowwhere to start the search for the feeder vessels.
	Results: Bench test were conducted and were found acceptable and did not raiseany new issues of safety or effectiveness. All software validation data demonstratesthat the Subject Device is as safe and effective when compared to the PredicateDevice that is currently marketed for the same intended use.

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The Subject Device modifications do not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens' "syngo Application Software" (VD20), K173611

8. Nonclinical Performance Testing:

Non-clinical tests were conducted for the "syngo Application Software" (VE2) during product development.

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
5-40	General	Medical devices -Application of riskmanagement tomedical devices	14971	2012	ISO
13-97	Software/Informatics	Health software -Part 1: Generalrequirements forproduct safety	82304-1	2017	IEC
13-32	Radiology	Medical DeviceSoftware -Software life-cycle process	62304AC	20062008	AAMI ANSI IEC
5-114	General	Medical devices -Part 1 Applicationof usabilityengineering tomedical devices	62366-1	2015	IEC
13-38	Software/Informatics	Application of riskmanagement forIT - networksincorporatingmedical devices -Part 1: Roles,responsibilitiesand activities	80001-1	2010	IEC

Siemens claims conformance to the following performance standards:

The modifications described in this Premarket Notification were supported with verification and validation testing.

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 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with

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special controls for medical devices containing software. Non-clinical tests were conducted on "synqo Application Software" (VE2) during product development.

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

The Human Factor Usability Validation showed no safety relevant functions that need to be validated with a summative usability validation according to the IEC and FDA Guidelines. "syngo Application Software" (VE2) has been found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. No further risk mitigations are necessary.

Siemens 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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section is the required cybersecurity information.

Performance Verification/Validation & Test Report Summaries:

The Software features "syngo DynaCT Sine Spin", "syngo DynaCT Multiphase" and "syngo Embolization Guidance" performance functionality has been tested and validated. Verification and Validation testing in the form of Unit, Subsystem and System Integration testing as well as system validation testing were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

All verification and validation data demonstrate that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use.

The following bench testing was performed for the new features "syngo DynaCT Sine Spin", syngo Dyna3D High Speed and syngo DynaCT High Speed such as

Homogeneity of reconstructed image ●
Spatial Resolution ●
Contrast to Noise Ratio ●
Geometric Distortion

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Radiation Metrics CTDI, DAP ●
Artifact analysis ●
Gantry positioning accuracy ●
. z-direction Resolution (Reconstructed section thickness)

Bench testing was performed for the new feature syngo DynaCT Multiphase. A phantom study was performed to exclude a potential reduction in image quality over 10 runs.

Bench testing was performed for the modified feature "syngo Embolization Guidance". The feeder detection algorithm was validated in a study of randomly selected clinical cases with the result that it is additionally suitable for prostate arteries.

The comparison of technological characteristic, non-clinical performance data, clinical images, Human Factor Usability data, and software validation data demonstrates that the Subiect Device is as safe, and effective when compared to the Predicate Device that is currently marketed for the same intended use.

Siemens claims conformance to the following table of FDA Guidance Documents for this 510(k) submission.

FDA Guidance Document and Effective Date
1.	Guidance for Industry and FDA Staff – User Fees and Refunds for PremarketNotification Submissions 510(k)Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse toAccept Policy for 510(k)sDocument issued on January 30, 2018
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated510(k)s - Guidance for Industry and FDA StaffDocument issued on August 12, 2005
4.	Guidance for Industry and Food and Drug Administration Staff: The 510(k)Program: Evaluating Substantial Equivalence in Premarket Notifications[510(k)]Document Issued on July 28, 2014
5.	Guidance for Industry and FDA Staff: Guidance for the SubmissionPremarket Notifications for Medical Image Management DevicesDocument Issued on July 27, 2000
6.	Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical DevicesDocument issued on May 11, 2005
7.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf SoftwareUse in Medical DevicesDocument issued on September 9, 1999
8.	Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016
9.	Guidance for Industry and FDA Staff: Pediatric Information for X-rayImaging Device Premarket Notifications.Document issued on November 28, 2017
10	Guidance for Industry and FDA Staff: Content of Premarket Submissions for

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FDA Guidance Document and Effective Date
	Management of Cybersecurity in Medical devices.Document issued on October 2, 2014
11	Guidance for Industry and FDA Staff: Appropriate Use of VoluntaryConsensus Standards in Premarket Submission for Medical DevicesDocument issued on September 14, 2018

Summary of the performance Testing Data:

Performance tests were conducted to test the functionality of the "syngo Application Software" (VE2). These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness.

All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use.

9. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. Furthermore, the operators are health care professionals familiar with and responsible for the evaluating and post processing of medical images.

10. Conclusion as to Substantial Equivalence:

The predicate device "syngo Application Software" (VD20), K173611, was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the subject device "syngo Application Software" (VE2) acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristic, non-clinical performance data, clinical images, and software validation data demonstrates that the subject device is as safe, and effective when compared to the predicate device that is currently marketed for the same intended

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).