SYNGO.PLAZA VB10A

K132532 · Siemens AG Healthcare · LLZ · Dec 9, 2013 · Radiology

Device Facts

• Record ID: K132532
• Device Name: SYNGO.PLAZA VB10A
• Applicant: Siemens AG Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Dec 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for 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 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.

Device Story

syngo.plaza VB10A is a software-only Picture Archiving and Communication System (PACS) installed on standard IT hardware. It ingests digital medical images via DICOM and integrates with HIS/RIS for clinical workflow management. The system provides tools for image display, processing, reporting, and archiving. Physicians use the workstation to view images, perform measurements (distance, angle, area, perimeter), and utilize advanced post-processing applications (3D reconstruction, multiplanar reconstruction, intensity projections). The device supports mammography diagnosis when used with specific FDA-cleared hardware and image formats. It facilitates clinical decision-making by providing diagnostic-quality visualization and structured reporting. Benefits include centralized image management, efficient workflow integration, and diagnostic support for radiologists and clinicians in hospital or clinic settings.

Clinical Evidence

Bench testing only. Software verification and validation were performed at unit, integration, and system levels according to standards including IEC 62304, ISO 14971, and DICOM/HL7 standards. No clinical data was required or provided.

Technological Characteristics

Software-only system installed on Windows-based, manufacturer-independent workstations. Connectivity via TCP/IP, DICOM, and HL7. Supports JPEG lossless/lossy, RLE, and MPEG-II compression. Features include 2D/3D image processing, multiplanar reconstruction, and intensity projections. Complies with IEC 62304 (Safety Class B), ISO 14971, and DICOM/HL7 standards.

Indications for Use

Indicated for use by physicians for the display, processing, reading, reporting, communication, distribution, storage, and archiving of digital medical images, including mammography. For primary mammography diagnosis, requires uncompressed or non-lossy compressed images, preprocessed DICOM 'For Presentation' images, and FDA-cleared monitors/printers.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• syngo.plaza VA20A (K101666)

Submission Summary (Full Text)

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# 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: [phone] Telefax: [phone]

# 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:

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- II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
# Device Description and 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 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).

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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,<br>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 Communicatio<br>medical images, including mammographic images. supports the physician in diagnosis and treatment<br>System intended to display, process, read, report,<br>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 must<br>oe used. Also monitors (displays) and printers which<br>Reports. |
| | 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<br>(HIS / RIS) to enable customer specific workflow |
| | yngo.plaza optionally uses a variety of advance ostprocessing applications. | go.plaza optionally uses a variety of advance<br>stprocessing 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 standard<br>communication protocol DICOM. Additional fast<br>image transfer protocol for use inside syngo.plaza<br>VB10A | Standard network protocols like TCP / IP and standard<br>communication protocol DICOM. Additional fast<br>image transfer protocol for use inside syngo.plaza<br>VA20A. |
| Image data<br>compression | JPEG lossless with compression factor 2 to 3 on storage<br>(RAID) and before archiving (e.g. on NAS)<br>- Uncompressed - lossless JPEG<br>- Lossless JPEG - lossless JPEG<br> | JPEG lossless with compression factor 2 to 3 on storage<br>(RAID) and before archiving (e.g. on NAS)<br>- Uncompressed - lossless JPEG<br>- Lossless JPEG - lossless JPEG<br>- Lossless JPEG 2000 - lossless<br>JPEG 2000<br>- Lossy JPEG - displayed as received<br>- RLE - displayed as received<br>MPEG-II support |
| Image Short<br>Term storage | Internal and External online storage on configurable<br>RAID systems. Industrial standards apply. | Internal and External online storage on configurable<br>RAID systems. Industrial standards apply. |
| Image Long<br>Term storage | External archiving on external (not inside syngo.plaza)<br>archiving to either NAS storage systems or to any<br>external DICOM Long Term Archive. Industrial<br>standards apply. | External archiving on external (not inside syngo.plaza)<br>archiving devices (e.g. NAS and DVD-RAM).<br>Industrial standards apply. |
| User administration | Centralized user administration | Centralized user administration |
| Functionality | syngo.plaza VB10A | syngo.plaza VA20A |
| OEM Interface | syngo.plaza VB10A<br>syngo.via20 | EndoMap<br>Expert-i<br>syngo.x<br>syngo 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 Basic<br>syngo 3D Advanced<br>3D VesselMetrix | syngo 3D Basic<br>syngo 3D Advanced<br>3D 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 Algorithm<br>In syngo.plaza 2D Image processing Library<br>Region Calculation (Mammography) (calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)<br>3D Projection (Cross-Reference) (calculated: Co-ordinates of the projected points from one plane on other orthogonal planes)<br>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)<br>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 Algorithm<br>In syngo.plaza 2D Image processing Library<br>Region Calculation (Mammography) (calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)<br>3D Projection (Cross-Reference) (calculated: Co-ordinates of the projected points from one plane on other orthogonal planes)<br>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)<br>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) |

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| syngo.plaza VB10A | syngo.plaza VA20A |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| image in displayed window after performing any of the<br>affine operation) | image in displayed window after performing any of the<br>affine operation) |
| Distance: Line Measurement between 2 points,<br>calculation based on image pixel spacing value and the<br>length of the line between start and end points | Distance: Line Measurement between 2 points,<br>calculation based on image pixel spacing value and the<br>length of the line between start and end points |
| Angle: The angle between the two lines measured in<br>anti-clockwise direction | Angle: The angle between the two lines measured in<br>anti-clockwise direction |
| Area: The calculation of area of Circle, Ellipse,<br>Rectangle | Area: The calculation of area of Circle, Ellipse,<br>Rectangle |
| Perimeter: The calculation of perimeter for Circle,<br>Rectangle: Average, Minimum and Maximum pixel<br>value and Standard Deviation calculation for the pixels<br>inside Circle, Ellipse and Distance line. | Perimeter: The calculation of perimeter for Circle,<br>Rectangle: Average, Minimum and Maximum pixel<br>value and Standard Deviation calculation for the pixels<br>inside Circle, Ellipse and Distance line. |
| Volume: no volume measurements in syngo.plaza | Volume: no volume measurements in syngo.plaza |
| Rendering Algorithm<br>In 3D application by Voxar | Rendering Algorithm<br>In 3D application by Voxar |
| Multiplanar Reconstruction (calculated: Images in one<br>plane are used to reconstruct images of other orthogonal<br>planes) | Multiplanar Reconstruction (calculated: Images in one<br>plane are used to reconstruct images of other orthogonal<br>planes) |
| Maximum and Minimum Intensity Projection<br>(calculated: Visualization of Maximum and minimum<br>voxel values that are visible projected to parallel plane) | Maximum and Minimum Intensity Projection<br>(calculated: Visualization of Maximum and minimum<br>voxel values that are visible projected to parallel plane) |
| Volume Rendering Technique (calculated: Visualization of<br>3D volume) | Volume Rendering Technique (calculated: Visualization of<br>3D volume) |
| Shaded Surface Display (calculated: Visualization of<br>Surface rendered 3D volume) | Shaded Surface Display (calculated: Visualization of<br>Surface rendered 3D volume) |
| In syngo.plaza 2D Image processing Library | In syngo.plaza 2D Image processing Library |

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| Functionality | syngo.plaza VB10A | syngo.plaza VA20A |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nearest-Neighbour interpolation (Smoothing)<br>(calculated: Estimated Pixel intensity based on nearest<br>neighbour algorithm)<br>Bilinear interpolation (Smoothing) (calculated:<br>Estimated Pixel intensity based on bilinear algorithm)<br>Bicubic interpolation (Smoothing) (calculated:<br>Estimated Pixel intensity based on bicubic algorithm)<br>8-bit Greyscale image display using Windows GDI<br>(calculated: Rendered pixel intensity on the screen co-<br>ordinates)<br>24- bit colour Image display using Windows GDI<br>(calculated: Rendered pixel intensity on the screen co-<br>ordinates)<br>Windowing and LUT Mapping (Windowing)<br>(calculated: Pixel intensity transformation based on VOI<br>LUT and Presentation LUT information and convert to<br>raster format which can be rendered)<br>Image subtraction (DSA) (calculated: Pixel intensity<br>after subtracting the mask frame pixel intensity) | Nearest-Neighbour interpolation (Smoothing)<br>(calculated: Estimated Pixel intensity based on nearest<br>neighbour algorithm)<br>Bilinear interpolation (Smoothing) (calculated:<br>Estimated Pixel intensity based on bilinear algorithm)<br>Bicubic interpolation (Smoothing) (calculated:<br>Estimated Pixel intensity based on bicubic algorithm)<br>8-bit Greyscale image display using Windows GDI<br>(calculated: Rendered pixel intensity on the screen co-<br>ordinates)<br>24- bit colour Image display using Windows GDI<br>(calculated: Rendered pixel intensity on the screen co-<br>ordinates)<br>Windowing and LUT Mapping (Windowing)<br>(calculated: Pixel intensity transformation based on VOI<br>LUT and Presentation LUT information and convert to<br>raster format which can be rendered)<br>Image subtraction (DSA) (calculated: Pixel intensity<br>after subtracting the mask frame pixel intensity) |
| Introduction<br>Warnings<br>and Cautions | WARNINGS (Operator Manual)<br>No warnings are applicable for the medical device<br>syngo.plaza. The device is classified as Safety Class B<br>according to IEC 62304. Therefore cautions are<br>sufficient. The generic chapter in the introduction was…