syngo .plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital mages, including mammographic images. It supports the physician in diagnosis and treatment planning

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used

syngo .plaza also supports DICOM Structured Reports

In a comprehensive imaging suite, syngo .plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer-specific workflows

syngo .plaza optionally uses a variety of advanced postprocessing applications

Device Description

syngo®.plaza is a "software only"-system, to be installed on common IT hardware, matching the syngo®.plaza hardware requirements.

AI/ML Overview

The provided document is a 510(k) summary for the medical device syngo®.plaza. It states that No clinical studies were carried out for syngo®.plaza, all performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device. Therefore, a table of acceptance criteria and reported device performance related to clinical studies and elements like sample size, ground truth, and expert adjudication are not applicable as no such studies were conducted.

Instead, the document details non-clinical performance testing based on various international standards for software verification and validation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable as no clinical studies with specific performance metrics (sensitivity, specificity, AUROC, etc.) and acceptance criteria were performed. The equivalence is established through non-clinical testing aligned with the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable, as no clinical test set was used. The performance testing was non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable, as there was no test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies were carried out for syngo®.plaza".

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device "syngo®.plaza" is a Picture Archiving and Communication System (PACS) and is intended for use by a physician in diagnosis and treatment planning. It is not an AI algorithm that functions in a standalone capacity without "human-in-the-loop". Its purpose is to display, process, read, report, communicate, distribute, store, and archive digital images to support the physician.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies with a ground truth were performed.

8. The Sample Size for the Training Set

Not applicable, as the document describes a PACS system and does not refer to an AI algorithm that requires a training set in the conventional sense. The focus is on software verification and validation against established standards.

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

Not applicable, for the same reason as above.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of non-clinical performance testing activities conducted for software verification and validation.

Study Title/Description: Software verification and validation activities for syngo®.plaza VB30.
Methodology: The testing was carried out according to a set of international and industry standards, including:
- ISO 14971:2007 (Medical devices – Application of risk management to medical devices)
- IEC 62304 Edition 1.1 2015-06 (Medical device software – Software life cycle processes)
- IEC 82304-1 Edition 1.1 2016-10 (Health software – Part 1: General requirements for product safety)
- IEC 62366-1 Edition 1.0 2015-02 (Medical devices – Part 1: Application of usability engineering to medical devices)
- NEMA PS3 / ISO 12052:2017 (DICOM)
- ISO / IEC 10918-1:1994 + TC 1:2005 (JPEG)
- ISO / IEC 15444-1:2005 + TC 1:2007 (JPEG 2000)
- IEEE 3333.2.1:2015
- ISO / HL7 21731:2014 (HL7 Version 2.x)
Acceptance Criteria (Implied): The device (syngo®.plaza VB30) must perform as well as the predicate device (syngo®.plaza VB10A) and comply with the listed standards. Changes from the predicate were evaluated for safety and effectiveness impact, with the conclusion being "This update does not impact or change the safety and effective use of the product" for most listed differences.
Reported Device Performance: "After comparison of the test results with the software release acceptance criteria, Siemens Healthcare GmbH is of the opinion, that syngo®.plaza VB30 is substantially equivalent to and performs as well as the predicate device syngo®.plaza VB10A." This statement confirms the device met its non-clinical acceptance criteria by demonstrating substantial equivalence and performance comparable to the predicate.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized image of a human figure.

April 25, 2018

Siemens Healthcare GmbH % Mr. Alexander Schapovalov Responsible Third Party Official 510(k) TPR Deputv Program Manager TÜV SÜD America Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891

Re: K180563

Trade/Device Name: syngo®.plaza Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 11, 2018 Received: April 16, 2018

Dear Mr. Schapovalov:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Mr. Schapovalov

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180563

Device Name syngo®.plaza

Indications for Use (Describe)

syngo .plaza also supports DICOM Structured Reports

In a comprehensive imaging suite, syngo .plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer-specific workflows

syngo .plaza optionally uses a variety of advanced postprocessing applications

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in all caps on the top line, and the word "Healthineers" is written on the second line. To the right of the words is a graphic of several small circles.

Traditional 510(k) Summary

syngo®.plaza VB30

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.

1. Submitter

Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany

2. Establishment Registration Number

3002808157

3. Contact Person

Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH Hartmanstrasse 16 91052 Erlangen Germany Telephone: +49 172 432 4369 +49 (9131) 84-8691 Telefax: Email: vijay.ramadas@siemens-healthineers.com

4. Device Name and Classification

Product Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

syngo®.plaza Picture Archiving and Communications System Radiology 21 CFR §892.2050 Class II LLZ

5. Legally Marketed Predicate Device

Product Name:	syngo®.plaza
510(k) Number:	K132532
Clearance Date	December 09, 2013

6. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

6.1 Intended Use

syngo@.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning

For primary image diagnosis in Mammography only uncompressed or nonlossy compressed images and only preprocessed DICOM "For Presentation"

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images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used

syngo®.plaza also supports DICOM Structured Reports

In a comprehensive imaging suite, syngo®.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows

syngo®.plaza optionally uses a variety of advanced postprocessing applications

6.2 Technological Characteristics

syngo®.plaza is a "software only"-system, to be installed on common IT hardware, matching the syngo®.plaza hardware requirements.

The above characteristics are also applicable for the predicate device syngo®.plaza VB10A (K132532)

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Summary of Comparison between Subject and Predicate Devic 1-

The following matrix describes the differences between syngo®.plaza VB30 to the predicate device syngo®.plaza VB10A

510(k) for syngo®.plaza

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syngo®.plaza VB30	Similarities and DifferencesDescription	Safety and EffectivenessImpact
reporting functionality issame as in the existingReporting Client	Mitigations wereimplemented and verified.The Risks Mitigations aresame as the existingReporting Client	NA
syngo®.plaza VB10A	It is a pure post-processingsoftware and has Noinfluence	NA
None	None	NA
None	No CAD functionalities inthe product	NA

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Clinical Testing 8.

No clinical studies were carried out for syngo®.plaza, all performance testing was conducted in a non-clinical fashion as part of the verification and validation activities fir the medical device

9. Non-Clinical Performance Testing

The software verification and validation was performed for the complete system according the following standards:

ISO 14971:2007 。
IEC 62304 Edition 1.1 2015-06 -
IEC 82304-1 Edition 1.1 2016-10 -
IEC 62366-1 Edition 1.0 2015-02 -
NEMA PS3 / ISO 12052:2017 (DICOM) -
ISO / IEC 10918-1:1994 + TC 1:2005 -
ISO / IEC 15444-1:2005 + TC 1:2007 =
-IEEE 3333.2.1:2015
ISO / HL7 21731:2014 (HL7 Version 2.x) -

After comparison of the test results with the software release acceptance criteria, Siemens Healthcare GmbH is of the opinion, that syngo@.plaza VB30 is substantially equivalent to and performs as well as the predicate device syngo®.plaza VB10A

10. General Safety and Effectiveness Information

The device labeling contains instructions for use and necessary cautions for safe and effective use of the device. Risk Management was implemented throughout the development process to control potential hazards

The device does not come into contact with the patient and is only used by trained professionals. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation

Siemens Healthcare GmbH believes that syngo®.plaza VB30 is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns

11. Substantial Equivalence

The syngo®.plaza, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

Manufacturer	Predicate Device	FDA Clearance Number	Clearance Date
Siemens AG Healthcare	syngo®.plaza VB10A	K132532	December 09, 2013

The syngo®.plaza described in this 510(k) has the same intended use and similar technical characteristics as the predicate device listed above in regard to the specific functionalities.

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12. Conclusion

In summary, Siemens Healthcare GmbH is of the opinion that syngo®.plaza VB30 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
Manufacturer	Siemens Healthcare GbmH	Siemens AG Medical Solutions	Legal Manufacturer change	NA
Intended Use	syngo®.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be	syngo®.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be	In VB30, the following was removed in the Intended Use statement, - “Note: Web-based image distribution is not intended for reporting ”, because the reporting was enabled in Web Client in VB30 when compared to the predicate device VB10A. This change was achieved by extending the reporting functionality from Reporting Client to Web Client and this is not a new functionality	This update does not impact or change the safety and effective use of the product
	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
	used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo®.plaza also supports DICOM Structured Reports.	used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo®.plaza also supports DICOM Structured Reports.
	In a comprehensive imaging suite, syngo®.plaza integrates Hospital / Radiological Information Systems (HIS / RIS) to enable customer specific workflows.	In a comprehensive imaging suite, syngo®.plaza integrates Hospital / Radiological Information Systems (HIS / RIS) to enable customer specific workflows.
	syngo®.plaza optionally uses a variety of advanced postprocessing applications.	syngo®.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.
Supported Modalities	CT, MR, Ultrasound and X-Ray	CT, MR, Ultrasound and X-Ray	Same	NA
Image Communication	Standard network protocols like TCP / IP and standard communication protocol	Standard network protocols like TCP / IP and standard communication protocol	Same	NA
	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
Image data compression	DICOM. Additional fast image transfer protocol for use inside syngoⓇ.plazaJPEG lossless with compression factor 2 to 3 on storage (RAID) and before archiving (e.g. on NAS)- Uncompressed - lossless JPEG- Lossless JPEG - lossless JPEG- Lossless JPEG 2000 – losslessJPEG 2000- Lossy JPEG - displayed as received- RLE - displayed as received- MPEG-II support	DICOM. Additional fast image transfer protocol for use inside syngoⓇ.plazaJPEG lossless with compression factor 2 to 3 on storage (RAID) and before archiving (e.g. on NAS)- Uncompressed - lossless JPEG- Lossless JPEG - lossless JPEG- Lossless JPEG 2000 – losslessJPEG 2000- Lossy JPEG - displayed as received- RLE - displayed as received- MPEG-II support	Same	NA
Image Short Term storage	Internal and External online storage on configurable RAID systems. Industrial standards apply	Internal and External online storage on configurable RAID systems. Industrial standards apply	Same	NA
Image Long Term storage	External archiving on external (not inside	External archiving (not inside syngo.plaza) to either	Rephrased for clarity, no change	NA
	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
	syngoⓇ.plaza) archiving to either NAS storage systems or to any external DICOM Long Term Archive. Industrial standards apply	NAS storage systems or to any external DICOM Long Term Archive. Industrial standards apply	Same	NA
User administration	Centralized user administration	Centralized user administration	Same	NA
OEM Interface	syngoⓇ.via	syngoⓇ.via	Same	NA
RIS communication	Improved: Via standards HL7 and DICOM, aligned to IHE Framework Rev.14	Via standards HL7 and DICOM, aligned to IHE Framework Rev.1.	Few new IHE profiles were added to enable larger integrated solution	This update does not impact or change the safety and effective use of the product
Hardware	Windows based, manufacturer independent workstations	Windows based, manufacturer independent workstations	Same	NA
Client Installation	Improved: Client software distribution with Automatic Update/Upgrade	Client software distribution for syngo®.plaza Reporting Clients	When a user logs into client, the client automatically checks with the syngo®.plaza server for an updated version of the client. If any new version is available, then client is automatically updated	This update does not impact or change the safety and effective use of the product
Application package / workplace functionality	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
syngo 3D Basic syngo 3D Advanced 3D VesselMetrix Filming Teleradiology Patient Media Creation Workflow Support for Mammography Spine Labeling / Cross Reference Cardio Thoracic Ratio (CTR) DSA Viewer Token view Smart Read Angle on Stack Patient ID New: Progressive Loading Improved: syngo.via Fast 3D call-up Improved: Align zoom factor based on Field of View (FoV) Improved: Viewing of Digital Breast	syngo 3D Basic syngo 3D Advanced 3D VesselMetrix Filming Teleradiology Patient Media Creation Workflow Support for Mammography Spine Labeling / Cross Reference Cardio Thoracic Ratio (CTR) DSA Viewer Token view Smart Read Angle on Stack Patient ID	The updates are made to enhance system performance and provide more options to the end user. All the Improvements and New implementation were analysed for Risk and Mitigations were implemented and verified	This update does not impact or change the safety and effective use of the product
	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
ImageProcessing	TomosynthesisImproved: Series synchronization Improved: Multi Cine and Smart Streaming Filming 3D Reconstruction 3D Vessel Metrix Rendering Workflow Support for mammography Spine Labeling / Cross Reference Cardio Thoracic Ratio (CTR) DSA Viewer	Filming 3D Reconstruction 3D Vessel Metrix Rendering Workflow Support for mammography Spine Labeling / Cross Reference Cardio Thoracic Ratio (CTR) DSA Viewer	Same	NA
Image Proces-singAlgorithms	Quantitative AlgorithmIn syngo.plaza 2D Image processing LibraryRegion Calculation (Mammography)(calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)3D Projection (Cross-	Quantitative AlgorithmIn syngo.plaza 2D Image processing LibraryRegion Calculation (Mammography)(calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)3D Projection (Cross-	Same	NA
syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
Reference) (calculated: Coordinates of the projected points from one plane on other orthogonal planes)	Reference) (calculated: Coordinates of the projected points from one plane on other orthogonal planes)
Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values	Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values
(calculated: Statistical values based on image pixel intensity in a given ROI)	(calculated: Statistical values based on image pixel intensity in a given ROI)
Affine Transformation (Zoom/Pan/Rotate/Flip)	Affine Transformation (Zoom/Pan/Rotate/Flip)
(calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation)	(calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation)
In syngo.plaza 2D Image processing Library Region Calculation (Mammography)	In syngo.plaza 2D Image processing Library Region Calculation (Mammography)
(calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)	(calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)
syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
3D Projection (Cross-Reference) (calculated: Co-ordinates of the projected points from one plane on other orthogonal planes)Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values	3D Projection (Cross-Reference) (calculated: Co-ordinates of the projected points from one plane on other orthogonal planes)Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values
(calculated: Statistical values based on image pixel intensity in a given ROI)Affine Transformation (Zoom/Pan/Rotate/Flip)(calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation)	(calculated: Statistical values based on image pixel intensity in a given ROI)Affine Transformation (Zoom/Pan/Rotate/Flip)(calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation)
Distance: Line Measurement between 2 points, calculation based on image pixel spacing value and the length of the line between start and end pointsAngle: The angle between the two lines measured in	Distance: Line Measurement between 2 points, calculation based on image pixel spacing value and the length of the line between start and end pointsAngle: The angle between the two lines measured in
syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
anti-clockwise directionArea: The calculation of areaof Circle, Ellipse, RectanglePerimeter: The calculation ofperimeter for Circle,Rectangle: Average,Minimum and Maximumpixel value and StandardDeviation calculation for thepixels inside Circle, Ellipseand Distance line.Volume: no volumemeasurements in syngo.plaza	anti-clockwise directionArea: The calculation of areaof Circle, Ellipse, RectanglePerimeter: The calculation ofperimeter for Circle,Rectangle: Average,Minimum and Maximumpixel value and StandardDeviation calculation for thepixels inside Circle, Ellipseand Distance line.Volume: no volumemeasurements in syngo.plaza
Rendering AlgorithmIn 3D application by VoxarMultiplanar Reconstruction(calculated: Images in oneplane are used to reconstructimages of other orthogonalplanes)Maximum and MinimumIntensity Projection(calculated: Visualization ofMaximum and minimumvoxel values that are visibleprojected to parallel plane)	Rendering AlgorithmIn 3D application by VoxarMultiplanar Reconstruction(calculated: Images in oneplane are used to reconstructimages of other orthogonalplanes)Maximum and MinimumIntensity Projection(calculated: Visualization ofMaximum and minimumvoxel values that are visibleprojected to parallel plane)
	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
	Volume RenderingTechnique (calculated:Visualization of 3D volume)Shaded Surface Display(calculated: Visualization ofSurface rendered 3D volume)In syngo.plaza 2D Imageprocessing LibraryNearest-Neighbourinterpolation (Smoothing)(calculated: Estimated Pixelintensity based on nearestneighbour algorithm)Bilinear interpolation(Smoothing) (calculated:Estimated Pixel intensitybased on bilinear algorithm)Bicubic interpolation(Smoothing) (calculated:Estimated Pixel intensitybased on bicubic algorithm)8-bit Greyscale imagedisplay using Windows GDI(calculated: Rendered pixelintensity on the screen co-ordinates)	Volume RenderingTechnique (calculated:Visualization of 3D volume)Shaded Surface Display(calculated: Visualization ofSurface rendered 3D volume)In syngo.plaza 2D Imageprocessing LibraryNearest-Neighbourinterpolation (Smoothing)(calculated: Estimated Pixelintensity based on nearestneighbour algorithm)Bilinear interpolation(Smoothing) (calculated:Estimated Pixel intensitybased on bilinear algorithm)Bicubic interpolation(Smoothing) (calculated:Estimated Pixel intensitybased on bicubic algorithm)8-bit Greyscale imagedisplay using Windows GDI(calculated: Rendered pixelintensity on the screen co-ordinates)
	syngo®.plaza VB30	syngo®.plaza VB10A	Similarities and Differences Description	Safety and Effectiveness Impact
	24- bit colour Image display using Windows GDI(calculated: Rendered pixel intensity on the screen co-ordinates)Windowing and LUTMapping (Windowing)(calculated: Pixel intensity transformation based on VOI LUT and Presentation LUT information and convert to raster format which can be rendered)Image subtraction (DSA)(calculated: Pixel intensity after subtracting the mask frame pixel intensity)	24- bit colour Image display using Windows GDI(calculated: Rendered pixel intensity on the screen co-ordinates)Windowing and LUTMapping (Windowing)(calculated: Pixel intensity transformation based on VOI LUT and Presentation LUT information and convert to raster format which can be rendered)Image subtraction (DSA)(calculated: Pixel intensity after subtracting the mask frame pixel intensity)	Same	NA
Cyber Security	Login with encryptionRecommended VirusScannersSoftware BlacklistSystem Hardening	Login with encryptionRecommended VirusScannersSoftware BlacklistSystem Hardening
Web Client	Improved: Web Client now allows the users to edit and save, thus reporting is made	Web client is not intended to be used for Reporting.Reporting is available ONLY	The updates are made to provide more options to the end user. The improvement	This update does not impact or change the safety and effective use of the product