syngo.plaza

K180563 · Siemens Healthcare GmbH · LLZ · Apr 25, 2018 · Radiology

Device Facts

• Record ID: K180563
• Device Name: syngo.plaza
• Applicant: Siemens Healthcare GmbH
• Product Code: LLZ · Radiology
• Decision Date: Apr 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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.

Device Story

syngo®.plaza is a software-only Picture Archiving and Communication System (PACS) installed on standard IT hardware. It ingests digital medical images (CT, MR, Ultrasound, X-Ray) via standard network protocols (TCP/IP, DICOM). The system provides tools for image viewing, 3D reconstruction, post-processing, and reporting. It integrates with HIS/RIS to support clinical workflows. Physicians and radiologists use the system to view images, perform measurements (distance, angle, area, perimeter), and generate reports. The device facilitates diagnosis and treatment planning by providing advanced visualization and quantitative analysis tools. It is used in clinical environments by trained healthcare professionals. The system supports automated client updates and secure data handling.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical performance testing, including software verification and validation activities performed according to established standards (ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1, NEMA PS3/ISO 12052, etc.).

Technological Characteristics

Software-only system for standard IT hardware. Supports DICOM, HL7, and IHE frameworks. Features include 2D/3D image processing, quantitative analysis (region calculation, statistical algorithms), and affine transformations. Connectivity via TCP/IP. Cybersecurity includes login encryption, virus scanning, software blacklisting, and system hardening. Complies with DICOM (NEMA PS3/ISO 12052) and HL7 standards.

Indications for Use

Indicated for use by trained professionals to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammography, for diagnosis and treatment planning.

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 VB10A (K132532)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] [phone] Telefax: Email: [e-mail]

#### 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

| | 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 <i>not intended for reporting</i> ”, 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Ⓡ.plaza<br>JPEG lossless with compression factor 2 to 3 on storage (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 | DICOM. Additional fast image transfer protocol for use inside syngoⓇ.plaza<br>JPEG lossless with compression factor 2 to 3 on storage (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 | 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 |
| Image<br>Processing | Tomosynthesis<br>Improved: 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-<br>sing<br>Algorithms | Quantitative Algorithm<br>In syngo.plaza 2D Image processing Library<br>Region Calculation (Mammography)<br>(calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)<br>3D Projection (Cross- | Quantitative Algorithm<br>In syngo.plaza 2D Image processing Library<br>Region Calculation (Mammography)<br>(calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity)<br>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)…