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 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. Note: Web-based image distribution is not intended for reporting. syngo.plaza is a "software only"-system. which will be delivered on DVD to be installed on common IT hardware, matching the syngo.plaza hardware requirements. syngo.plaza will be installed by Siemens implementation engineers. The integration into customer specific 17 environments is offered based on professional services. Updates / upgrades are offered based on service contracts and fulfilled by trained service technicians.

AI/ML Overview

The provided text describes the Siemens syngo.plaza VB10A, a Picture Archiving and Communication System (PACS), and its substantial equivalence to a predicate device (syngo.plaza VA20A). It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of submission generally does not include extensive clinical studies or detailed performance metrics against specific acceptance criteria. Instead, it relies on demonstrating similar technical and functional characteristics to a previously cleared device.

Therefore, many of the requested details regarding acceptance criteria, specific performance metrics, and detailed study information are not present in the provided document, as they are not typically required for a 510(k) submission for a PACS device of this nature. The information below is extracted or inferred from the provided text where possible, and explicitly states where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for aPACS device, "acceptance criteria" are primarily related to functional equivalence, adherence to standards, and safety. There are no quantitative diagnostic performance metrics presented for the device itself in this document. The "performance" is largely described in terms of functional parity with the predicate device and adherence to listed standards.

Acceptance Criteria Category	Description of "Acceptance" (as inferred from document)	Reported Device Performance (as described in the document)
Functional Equivalence	The device must have substantially equivalent intended use and similar technical characteristics as the predicate device (syngo.plaza VA20A) for specific functionalities. This is the primary "acceptance criterion" for a 510(k) submission of this type.	The document provides extensive tables comparing the functionalities of syngo.plaza VB10A with syngo.plaza VA20A, detailing features such as image communication, data compression, storage, user administration, OEM interfaces, user interface, RIS communication, hardware, client installation, application packages, image processing features, and image processing algorithms. The conclusion states that "syngo.plaza VB10A does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device." New features like "Token view," "Smart Read feature," "Angle on Stack" functionality, and "Patient ID" are introduced, but the overall functionality is deemed equivalent.
Safety and Effectiveness (General)	The device labeling must contain instructions for use, cautions, and warnings to ensure safe and effective use. Risk management processes must identify potential hazards and control them through software development, verification, and validation testing, adhering to recognized industry practices and standards.	The device labeling includes instructions, cautions, and warnings (updated for clarity and scope compared to predicate). Risk management was performed via a risk analysis (RIM115291/mv300_risk_1-11.1 and RIM115372/plaza_risk_PatientIdentification-Truncation_CDR) during software development, verification, and validation to minimize identified hazards. The device is classified as Safety Class B according to IEC 62304.
Adherence to Standards	The software verification and validation (Unit Test, Integration Test, System Test) for all newly developed components and the complete system must be performed according to specified international and FDA-recognized standards.	Verification and validation were performed according to: ISO 14971:2007 (DIN EN ISO 14971:2012 used in Germany), AIMI/ANSI ES 60601-1:2005/(R) 2012 + C1:2009/(R) 2012 (clause 14), IEC 62304:2006, IEC 62366:2007, DICOM Standard [2011], HL7 [2006], ISO / IEC 10918-1:1994 + TC 1:2005, ISO / IEC 15444-1:2005+TC 1:2007, ISO / IEC 13818:2009. The device conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards.
Mammography Imaging	For primary image diagnosis in Mammography, only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Additionally, monitors (displays) and printers which have received FDA clearance for Mammography must be used.	The device's intended use explicitly states these requirements for mammography images. This is a user requirement, not a direct performance metric of the software itself, but rather a proper use condition it is designed to support.

Note: This document does not contain quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) for image interpretation, as the device is a PACS for display and management, not a diagnostic algorithm that provides an output needing validation against clinical outcomes. The "study" here is primarily a series of verification and validation activities against engineering and regulatory standards, and a comparison against a predicate device.

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

The document describes non-clinical testing including Unit Test Level, Integration Test Level, and System Test Level performed for newly developed components and the complete system. This implies testing against technical specifications and requirements, rather than a "test set" of patient data in the clinical sense for performance evaluation.

Sample Size for Test Set: Not specified. The document does not refer to a "test set" in terms of patient cases or images for evaluating diagnostic performance. Testing was for software functionality, safety, and adherence to standards.
Data Provenance: Not applicable/Not specified. As this is primarily software verification and validation, there is no mention of country of origin for clinical data or whether it was retrospective or prospective. The testing would have involved simulated data, test cases designed to check functionalities, and potentially a range of DICOM images to ensure compatibility and correct display/processing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/Not specified. Since this is a PACS system and the application is for functional equivalence, there is no mention of expert radiologists establishing ground truth for diagnostic purposes within this 510(k) summary. The "ground truth" for software functionality would be the defined specifications and expected behavior, tested by software engineers and quality assurance personnel.

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

Adjudication Method: Not applicable. Given that the testing is focused on software functionality, safety, and adherence to standards, the concept of "adjudication" for a clinical test set is not present in this document.

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

MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers utilized AI. The device is a PACS system, not an AI-powered diagnostic aide.

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

Standalone Performance Study: No. This device is a PACS and its function is to display, process, and manage medical images for human interpretation, not to provide standalone diagnostic outputs. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

Type of Ground Truth: Not applicable/Not specified for clinical outcomes. For the software verification and validation, the "ground truth" would be the documented functional requirements, design specifications, and expected outputs of the software features (e.g., correct image display, accurate measurements, proper storage, and retrieval). There is no mention of clinical ground truth (like pathology or outcomes data) being used to evaluate the device's performance in a diagnostic capacity.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. As the device is a PACS system and not an AI/ML algorithm that requires training data in the diagnostic sense, there is no mention of a "training set."

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

Ground Truth for Training Set: Not applicable. See point 8.

Summary

{0}------------------------------------------------

K 132532 DEC - 9 2013

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.

3002808157 .

· I. GENERAL INFORMATION

Establishment:

Address:

Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany .

Registration Number: .

LLZ

Contact Person: .

Viktoria Benz Regulatory Affairs Manager Telephone: +49 (9131) 84-4483 Telefax: +49 (9131) 84-8691

Device Name and Classification:

Trade Name: syngo.plaza VB10A · Classification Name: Picture Archiving and Communications System Classification Panel: Radiology 21 CFR §892.2050 CFR Section: Device Class: Class II

Product Code:

{1}------------------------------------------------

II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

Device Description and Intended Use:

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.

Note:

Web-based image distribution is not intended for reporting.

Technological Characteristics:

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

syngo.plaza will be installed by Siemens implementation engineers.

The integration into customer specific 17 environments is offered based on professional services. Updates / upgrades are offered based on service contracts and fulfilled by trained service technicians.

This is also applicable for the predicate device syngo.plaza VA20A (K101666).

{2}------------------------------------------------

he following matrix compares the functionality of the syngo.plaza VBI0A to the predicate device syngo.plaza VA20A

nctionalit	vngo.plaza VB10A	syngo.plaza VA20A
lanufacture	emens AG Medical Solutions	Siemens AG Medical Solutions
ntended Use	yngo.plaza is a Picture Archiving and Communication tystem intended to display, process, read, report,communicate, distribute, store, and archive digital medical images, including mammographic images. supports the physician in diagnosis and treatment planning.	ngo.plaza is a Picture Archiving and Communicatiomedical images, including mammographic images. supports the physician in diagnosis and treatmentSystem intended to display, process, read, report,olanning.
	For primary image diagnosia in Mammography andy unggunan aran masar Press Premarianian Marin Marin Marin Marin Marin Marin Marin Marin Marin Marina Maceined FDA monimors (dis	or primary image diagnosis in Mammography only compressed or non-lossy compressed images and only eprocessed DICOM "For Presentation" images mustoe used. Also monitors (displays) and printers whichReports.
	Integrates Hospital / Radiological Information System Integrates Hospital / Radiological Information System (HIS / RIS) to enable customer specific workflows.	a comprehensive imaging suite, syngo.plaza egrates Hospital / Radiological Information Syst(HIS / RIS) to enable customer specific workflow
	yngo.plaza optionally uses a variety of advance ostprocessing applications.	go.plaza optionally uses a variety of advancestprocessing applications
	ote: Web-based image distribution is not intended for	Note: Web-based image distribution is not intended
Functionality	syngo.plaza VB10A	syngo.plaza VA20A
	reporting.	reporting.
Image communication	Standard network protocols like TCP / IP and standardcommunication protocol DICOM. Additional fastimage transfer protocol for use inside syngo.plazaVB10A	Standard network protocols like TCP / IP and standardcommunication protocol DICOM. Additional fastimage transfer protocol for use inside syngo.plazaVA20A.
Image datacompression	JPEG lossless with compression factor 2 to 3 on storage(RAID) and before archiving (e.g. on NAS)- Uncompressed - lossless JPEG- Lossless JPEG - lossless JPEG	JPEG 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 receivedMPEG-II support
Image ShortTerm storage	Internal and External online storage on configurableRAID systems. Industrial standards apply.	Internal and External online storage on configurableRAID systems. Industrial standards apply.
Image LongTerm storage	External archiving on external (not inside syngo.plaza)archiving to either NAS storage systems or to anyexternal DICOM Long Term Archive. Industrialstandards apply.	External archiving on external (not inside syngo.plaza)archiving devices (e.g. NAS and DVD-RAM).Industrial standards apply.
User administration	Centralized user administration	Centralized user administration
Functionality	syngo.plaza VB10A	syngo.plaza VA20A
OEM Interface	syngo.plaza VB10Asyngo.via20	EndoMapExpert-isyngo.xsyngo MammoReport
User Interface	UI is one of the syngo.plaza VB10A workstation deployments.	UI is one of the syngo.plaza VA20A workstation deployments.
RIS communication	Via standards HL7 and DICOM. aligned to IHE Framework Rev.1.	Via standards HL7 and DICOM. aligned to IHE Framework Rev.9.
Hardware	Windows based, manufacturer independent Workstations	Windows based, manufacturer independent Workstations: PC based with Windows XP or Windows Vista;
Client Installation	New: Introduction of a client software distribution for syngo.plaza Reporting Clients	manual installation using MSI packages
Application package / workplace function-	syngo 3D Basicsyngo 3D Advanced3D VesselMetrix	syngo 3D Basicsyngo 3D Advanced3D VesselMetrix
Functionality	syngo.plaza VB10A	syngo.plaza VA20A
nality	Filming	Filming
	Teleradiology	Teleradiology
	Patient Media Creation	Scanner
	Workflow Support for Mammography	Patient Media Creation
	Spine Labeling / Cross Reference	Workflow Support for Mammography
	Cardio Thoracic Ratio (CTR10)	Spine Labeling / Triangulations
	DSA Viewer	Cardio Thoracic Ratio (CTR10)
	New: Token view	DSA Viewer
	New: Smart Read feature
	New: Angle on Stack" functionality
	New: Patient ID
Image Processing features	Filming	Filming
	3D Reconstruction	3D Reconstruction
	3D Vessel Metrix	3D Vessel Metrix
	Rendering	Rendering
	Workflow Support for mammography	Workflow Support for mammography
	Spine Labeling / Cross Reference	Spine Labeling / Triangulations
	Cardio Thoracic Ratio (CTR10)	Cardio Thoracic Ratio (CTR10)
	DSA Viewer	DSA Viewer

Functionality	syngo.plaza VBI0A	syngo.plaza VA20A
Image Processing Algorithms	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-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)	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-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)

July 30. 2013

Page K 4

510(k) for syngo®0.plaza

{3}------------------------------------------------

July 30. 2013

510(k) for syngo®.plaza

Page K 5

{4}------------------------------------------------

. "

10 Via internal reorganization syngo.x was renamed to syngo,via.

July 30, 2013

510(k) for syngo®.plaza

Page K 6

{5}------------------------------------------------

ﻨﻨﻪ،

Page K 7

{6}------------------------------------------------

ﯩﺪ :

Page K 8

510(k) for syngo®.plaza

July 30. 2013

for syngas plants

{7}------------------------------------------------

syngo.plaza VB10A	syngo.plaza VA20A
image in displayed window after performing any of theaffine operation)	image in displayed window after performing any of theaffine operation)
Distance: Line Measurement between 2 points,calculation based on image pixel spacing value and thelength of the line between start and end points	Distance: Line Measurement between 2 points,calculation based on image pixel spacing value and thelength of the line between start and end points
Angle: The angle between the two lines measured inanti-clockwise direction	Angle: The angle between the two lines measured inanti-clockwise direction
Area: The calculation of area of Circle, Ellipse,Rectangle	Area: The calculation of area of Circle, Ellipse,Rectangle
Perimeter: The calculation of perimeter for Circle,Rectangle: Average, Minimum and Maximum pixelvalue and Standard Deviation calculation for the pixelsinside Circle, Ellipse and Distance line.	Perimeter: The calculation of perimeter for Circle,Rectangle: Average, Minimum and Maximum pixelvalue and Standard Deviation calculation for the pixelsinside Circle, Ellipse and Distance line.
Volume: no volume measurements in syngo.plaza	Volume: no volume measurements in syngo.plaza
Rendering AlgorithmIn 3D application by Voxar	Rendering AlgorithmIn 3D application by Voxar
Multiplanar Reconstruction (calculated: Images in oneplane are used to reconstruct images of other orthogonalplanes)	Multiplanar Reconstruction (calculated: Images in oneplane are used to reconstruct images of other orthogonalplanes)
Maximum and Minimum Intensity Projection(calculated: Visualization of Maximum and minimumvoxel values that are visible projected to parallel plane)	Maximum and Minimum Intensity Projection(calculated: Visualization of Maximum and minimumvoxel values that are visible projected to parallel plane)
Volume Rendering Technique (calculated: Visualization of3D volume)	Volume Rendering Technique (calculated: Visualization of3D volume)
Shaded Surface Display (calculated: Visualization ofSurface rendered 3D volume)	Shaded Surface Display (calculated: Visualization ofSurface rendered 3D volume)
In syngo.plaza 2D Image processing Library	In syngo.plaza 2D Image processing Library

ﻨﺪ ﻟﻠ

Page K 9

510(k) for syngo®.plaza

July 30, 2013

for single p.i.d.

{8}------------------------------------------------

Functionality	syngo.plaza VB10A	syngo.plaza VA20A
	Nearest-Neighbour interpolation (Smoothing)(calculated: Estimated Pixel intensity based on nearestneighbour algorithm)Bilinear interpolation (Smoothing) (calculated:Estimated Pixel intensity based on bilinear algorithm)Bicubic interpolation (Smoothing) (calculated:Estimated Pixel intensity based on bicubic algorithm)8-bit Greyscale image display using Windows GDI(calculated: Rendered pixel intensity on the screen co-ordinates)24- bit colour Image display using Windows GDI(calculated: Rendered pixel intensity on the screen co-ordinates)Windowing and LUT Mapping (Windowing)(calculated: Pixel intensity transformation based on VOILUT and Presentation LUT information and convert toraster format which can be rendered)Image subtraction (DSA) (calculated: Pixel intensityafter subtracting the mask frame pixel intensity)	Nearest-Neighbour interpolation (Smoothing)(calculated: Estimated Pixel intensity based on nearestneighbour algorithm)Bilinear interpolation (Smoothing) (calculated:Estimated Pixel intensity based on bilinear algorithm)Bicubic interpolation (Smoothing) (calculated:Estimated Pixel intensity based on bicubic algorithm)8-bit Greyscale image display using Windows GDI(calculated: Rendered pixel intensity on the screen co-ordinates)24- bit colour Image display using Windows GDI(calculated: Rendered pixel intensity on the screen co-ordinates)Windowing and LUT Mapping (Windowing)(calculated: Pixel intensity transformation based on VOILUT and Presentation LUT information and convert toraster format which can be rendered)Image subtraction (DSA) (calculated: Pixel intensityafter subtracting the mask frame pixel intensity)
IntroductionWarningsand Cautions	WARNINGS (Operator Manual)No warnings are applicable for the medical devicesyngo.plaza. The device is classified as Safety Class Baccording to IEC 62304. Therefore cautions aresufficient. The generic chapter in the introduction was	WARNINGS (Operator Manual)Warnings and cautions are specially marked in thedocumentation.The content of a Warning or a Caution is structured inthree different sections: Cause, Consequence, Remedy.Warning indicates potential danger that could cause

Page K 10

510(k) for syngo®.plaza

July 30, 2013

) for synergy, please

ﻨﺘﻬﺮ ﺑﻪ

•

{9}------------------------------------------------

Functionality	syngo.plaza VBIOA	syngo.plaza VA20A
	adapted accordingly. There are no implications by theremoving the warnings on the safe and proper use of thedevice.	injury or death in extreme cases.First, the source of danger is addressed!Then, possible consequences are described.Finally, measures are given to prevent a dangeroussituation.
	CAUTIONSThe wording was improved for better understanding:	CAUTIONSCaution indicates potential (direct) danger that couldcause minor injury or damage to the systemFirst, the source of danger is addressed!Then, possible consequences are described.Finally, measures are given to prevent a dangeroussituation.
	Cautions are specially marked in the documentation.The content of a caution is structured in three differentsections: Source of danger, Consequence,Countermeasure:CAUTION indicates potential risk that may result inminor physical injury or material damage.First, the source of danger is addressed!Then, possible consequences are described.Finally, measures are given to prevent a dangeroussituation.	To operate syngo.plaza safely, read the "SafetyAdvisory" chapter in this document. In this chapter, youfind a list of all relevant safety notices
		To operate syngo.plaza safely, read the "SafetyAdvisory" chapters in the syngo.plaza Operator Manual- User Manual and in the syngo.plaza Operator Manual -Administrator Manual.
User manualcontent	Image ReviewThe wording was improved for better understanding:	Image ReviewThe Viewer can be configured not to store imageediting.Loss of data
Cautions	Use of Viewer setting 'Never save changes' on closeLoss of findings when closing the study

Page K | I

510(k) for syngo®.plaza

July 30, 2013

.
for 15.12.

。・・・・・・

{10}------------------------------------------------

Functionality	syngo.plaza VB10A	syngo.plaza VA20A
	• Make sure that the checkbox 'Never save changes toloaded images' is not selected in the Viewer Settingsdialog box.- OR -• Click the Save Changes icon on the tool palette tosave edited images despite the setting.	• Make sure that the Never save changes to loadedimages option is not activated in the Viewer settings.- OR -• Click the Save Changes icon in the tool palette tosave edited images despite the setting.
	Receiving Imagesn.a. anymore - removed for user manual as the relatedrisk is mitigated per safe software design: See documentRisk Analysis, RIM115291/mv300_risk_1-11.1: “Thevalidation of the DICOM hierarchy is performed prior tostorage when an image is received or imported.” Thisrisk mitigation performs a check if the received imagesare in a valid DICOM hierarchy (structure) with thesoftware, it is not necessary any more that the userperforms it.	Receiving ImagesIncorrect structure generated in the image.Wrong diagnosis• Always perform a basic validation (syntactic andsemantic check) when you receive images.
	Scanned Imagesn.a. anymore - The scanner tab card has been removedfrom the VB10A application as the functionality isprovided from other vendors. See VB10A User Manualstatement "You can also import images in variousformats (JPEG, BMP, TIFF) into your database, or scanhard copies with a connected scanner (digitizing)."	Scanned ImagesScanned images can be cropped before saving.Irreversible cropping of images• Before saving the images, make sure you will notneed the original images.
	Write LockThe wording was improved for better understanding:	Write LockCancelling write lock on the server workplace manually.Loss of image modification data• Before cancelling the write lock, make sure that theclient with write authorization is no longer editing theimages.• You can find the name of the client with writeauthorization in the Host Name column in the PatientList.

, - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Page K 12

510(k) for syngo ki.plaza

July 30, 2013

ﻳﺒﻴﻊ

{11}------------------------------------------------

Functionality	syngo.plaza VB10A	syngo.plaza VA20A
Removing write lock on a series or study level manually.
Loss of image modification data
	Before unlocking the series or study, make sure that the user/client with write authorization is no longer editing the images. You will find the name/hostname of the user/client with write lock authorization in the "Reserved by" column in the Patient List.	Archive MediaImproper handling of archive media can result in illegible media.Loss of data due to damaged archive media Always comply with the instructions of the manufacturer when handling archive media. Please only use "medical" quality CD/DVD media recommended by Siemens.
	Archive Median.a. anymore - Archival is only allowed on NAS systems; CD/DVD is not intended as archive media
	Displayed Patient Datan.a. anymore - removed for user manual, the related risk is mitigated per safe software design: See document Risk Analysis,RIM115372/plaza_risk_PatientIdentification-Truncation_CDR "Ensure in worklist that patient name and patient ID will not be cut out due to improper space or indicate to the user that the full information is not displayed. Ensure that user can access the complete information". This risk mitigation gives an indication if text was cut-off and gives the user the possibility to look at the whole text, therefore no need to adress this in the user manual any more.	Displayed Patient DataText elements are too small.Patient information is cut off Note that patient information may not be fully displayed.

Page K 13

stocks for syngenta.pla

510(k) for syngo it.plaza

{12}------------------------------------------------

Functionality	syngo.plaza VB10A	syngo.plaza VA20A
Standards	SMPTE - n.a. anymore, syngo.plaza itself does notcomply to the SMPTE standard as the compliance tothis standard lies within the responsibility to thecustomer. This is communicated via User ManualChapter 2 on page 32 ("Approved calibrated monitorsare required for diagnostic workstations") and("Monitors that are used for medical reporting must becalibrated before use")	SMPTE (Society of Motion Picture and TelevisionEngineers) Test Pattern [1995] - Intended to testCRT monitors and printers used to display medicalimages for acceptance and quality control purposes.The conformance to this standard is ensured byverification activities as the usage of SMPTE pattern

په متحده -

Page K 14

July 30, 2013

510(k) for syngo®.plaza

{13}------------------------------------------------

Summary of Non-Clinical Testing:

The software verification and validation (Unit Test Level, Integration Test Level and System Test Level) was performed for all newly developed components and the complete system according the following standards:

ISO 14971:200721
AIMI/ANSI ES 60601-1:2005/(R) 2012 + C1:2009/(R) 2012, clause 14
IEC 62304:2006
IEC 62366:2007
DICOM Standard [2011]
HL7 [2006]
ISO / IEC 10918-1:1994 + TC 1:2005
ISO / IEC 15444-1:2005+TC 1:2007
ISO / IEC 13818:2009

After completion of the system test and comparison of the test results with the software release acceptance criteria, Siemens is of the opinion, that syngo.plaza is substantially equivalent to and performs as well as the predicate device.

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, veriffication and validation testing. To minimize hazards, Siemens adheres to recognized and established industry practice and standards.

syngo.plaza conforms to the applicable FDA recognized and international IEC, ISO. and NEMA standards with regards to performance and safety as recommended by the respective FDA Guidance Document.

Substantial Equivalence:

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

Manufacturer	Predicate Device Name	FDA ClearanceNumber
Siemens	syngo.plaza VA20A	K101666

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.

21 The submitted MRS document shows DIN EN ISO 14971:2012 version of this standard which is already recognized in Germany.

{14}------------------------------------------------

In summary, Siemens is of the opinion that syngo.plaza VB10A does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device. . . . . . - . : ・

・

.....

510(k) for syngo®.plaza

. .

. -

. .

・

: .

・

. ·

. .

July 30, 2013 ·

Page K 16 .

{15}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 9, 2013

Siemens AG Healthcare % Mr. Olaf Teichert Third Party Reviewer Tuv Sud America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K132532

Trade/Device Name: Syngo® plaza VB10A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 06, 2013 Received: November 12, 2013

Dear Mr. Teichert:

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

{16}------------------------------------------------

Page 2-Mr. Teichert

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{17}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):	K132532
Device Name:	syngo®.plaza VB10A

Indications For Use:

It supports the physician in diagnosis and treatment planning.

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.

Note:

Web-based image distribution is not intended for reporting.

X Prescription Use __ (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sm.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) = K132532

Page I of 1

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).