(119 days)
No
The document describes a standard PACS system with image processing capabilities and integration with HIS/RIS. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies summary. The focus is on image display, processing, storage, and workflow integration.
No.
The device is a Picture Archiving and Communication System (PACS) intended for displaying, processing, storing, and archiving digital medical images to support diagnosis and treatment planning. It does not actively treat or provide therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "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." The phrase "supports the physician in diagnosis" indicates it is a diagnostic device.
Yes
The device description explicitly states that syngo.plaza is a "software only"-system. While it requires common IT hardware for installation and operation, the device itself, as described and delivered, is solely the software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- syngo.plaza's function: syngo.plaza is a Picture Archiving and Communication System (PACS) that deals with medical images. It displays, processes, stores, and manages digital images obtained from imaging modalities like mammography. It does not analyze biological samples.
- Intended Use: The intended use clearly states its purpose is to support physicians in diagnosis and treatment planning based on medical images.
Therefore, syngo.plaza falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
LLZ
Device Description
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 I7 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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:
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).
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 Communicatio | |
| medical images, including mammographic images. supports the physician in diagnosis and treatment | ||
| System 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 must | |
| oe used. Also monitors (displays) and printers which | ||
| 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 | |
| (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 | |
| 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 | |
| communication protocol DICOM. Additional fast | ||
| image transfer protocol for use inside syngo.plaza | ||
| VB10A | Standard network protocols like TCP / IP and standard | |
| communication protocol DICOM. Additional fast | ||
| image transfer protocol for use inside syngo.plaza | ||
| VA20A. | ||
| Image data | ||
| compression | 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 - lossless
JPEG 2000 - Lossy JPEG - displayed as received
- RLE - displayed as received
MPEG-II support |
| 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. |
| Image Long
Term storage | External archiving on external (not inside syngo.plaza)
archiving to either NAS storage systems or to any
external DICOM Long Term Archive. Industrial
standards 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 VB10A
syngo.via20 | EndoMap
Expert-i
syngo.x
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
syngo 3D Advanced
3D VesselMetrix | syngo 3D Basic
syngo 3D Advanced
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
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)
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 Algorithm
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)
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) |
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10 Via internal reorganization syngo.x was renamed to syngo,via.
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| syngo.plaza VB10A | syngo.plaza VA20A |
|---|---|
| image in displayed window after performing any of the | |
| affine operation) | 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 points | Distance: Line Measurement between 2 points, |
| calculation based on image pixel spacing value and the | |
| length of the line between start and end points | |
| Angle: The angle between the two lines measured in | |
| anti-clockwise direction | Angle: The angle between the two lines measured in |
| anti-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 pixel | |
| value and Standard Deviation calculation for the pixels | |
| inside Circle, Ellipse and Distance line. | Perimeter: The calculation of perimeter for Circle, |
| Rectangle: Average, Minimum and Maximum pixel | |
| value and Standard Deviation calculation for the pixels | |
| inside Circle, Ellipse and Distance line. | |
| Volume: no volume measurements in syngo.plaza | Volume: no volume measurements in syngo.plaza |
| Rendering Algorithm | |
| In 3D application by Voxar | Rendering Algorithm |
| In 3D application by Voxar | |
| Multiplanar Reconstruction (calculated: Images in one | |
| plane are used to reconstruct images of other orthogonal | |
| planes) | Multiplanar Reconstruction (calculated: Images in one |
| plane are used to reconstruct images of other orthogonal | |
| planes) | |
| Maximum and Minimum Intensity Projection | |
| (calculated: Visualization of Maximum and minimum | |
| voxel values that are visible projected to parallel plane) | Maximum and Minimum Intensity Projection |
| (calculated: Visualization of Maximum and minimum | |
| voxel values that are visible projected to parallel plane) | |
| Volume Rendering Technique (calculated: Visualization of | |
| 3D volume) | Volume Rendering Technique (calculated: Visualization of |
| 3D volume) | |
| Shaded Surface Display (calculated: Visualization of | |
| Surface rendered 3D volume) | Shaded Surface Display (calculated: Visualization of |
| 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) | ||
| (calculated: Estimated Pixel intensity based on nearest | ||
| neighbour 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 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) | Nearest-Neighbour interpolation (Smoothing) | |
| (calculated: Estimated Pixel intensity based on nearest | ||
| neighbour 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 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) | ||
| Introduction | ||
| Warnings | ||
| and Cautions | WARNINGS (Operator Manual) | |
| No warnings are applicable for the medical device | ||
| syngo.plaza. The device is classified as Safety Class B | ||
| according to IEC 62304. Therefore cautions are | ||
| sufficient. The generic chapter in the introduction was | WARNINGS (Operator Manual) | |
| Warnings and cautions are specially marked in the | ||
| documentation. | ||
| The content of a Warning or a Caution is structured in | ||
| three different sections: Cause, Consequence, Remedy. | ||
| Warning indicates potential danger that could cause |
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| Functionality | syngo.plaza VBIOA | syngo.plaza VA20A |
|---|---|---|
| adapted accordingly. There are no implications by the | ||
| removing the warnings on the safe and proper use of the | ||
| device. | 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 dangerous | ||
| situation. | ||
| CAUTIONS | ||
| The wording was improved for better understanding: | CAUTIONS | |
| Caution indicates potential (direct) danger that could | ||
| cause minor injury or damage to the system | ||
| First, the source of danger is addressed! | ||
| Then, possible consequences are described. | ||
| Finally, measures are given to prevent a dangerous | ||
| situation. | ||
| Cautions are specially marked in the documentation. | ||
| The content of a caution is structured in three different | ||
| sections: Source of danger, Consequence, | ||
| Countermeasure: | ||
| CAUTION indicates potential risk that may result in | ||
| minor physical injury or material damage. | ||
| First, the source of danger is addressed! | ||
| Then, possible consequences are described. | ||
| Finally, measures are given to prevent a dangerous | ||
| situation. | To operate syngo.plaza safely, read the "Safety | |
| Advisory" chapter in this document. In this chapter, you | ||
| find a list of all relevant safety notices | ||
| To operate syngo.plaza safely, read the "Safety | ||
| Advisory" chapters in the syngo.plaza Operator Manual |
- User Manual and in the syngo.plaza Operator Manual -
Administrator Manual. |
| User manual
content | Image Review
The wording was improved for better understanding: | Image Review
The Viewer can be configured not to store image
editing.
Loss of data |
| Cautions | Use of Viewer setting 'Never save changes' on close
Loss of findings when closing the study | |
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| Functionality | syngo.plaza VB10A | syngo.plaza VA20A |
|---|---|---|
| • Make sure that the checkbox 'Never save changes to | ||
| loaded images' is not selected in the Viewer Settings | ||
| dialog box. |
- OR -
• Click the Save Changes icon on the tool palette to
save edited images despite the setting. | • Make sure that the Never save changes to loaded
images option is not activated in the Viewer settings. - OR -
• Click the Save Changes icon in the tool palette to
save edited images despite the setting. |
| | Receiving Images
n.a. anymore - removed for user manual as the related
risk is mitigated per safe software design: See document
Risk Analysis, RIM115291/mv300_risk_1-11.1: “The
validation of the DICOM hierarchy is performed prior to
storage when an image is received or imported.” This
risk mitigation performs a check if the received images
are in a valid DICOM hierarchy (structure) with the
software, it is not necessary any more that the user
performs it. | Receiving Images
Incorrect structure generated in the image.
Wrong diagnosis
• Always perform a basic validation (syntactic and
semantic check) when you receive images. |
| | Scanned Images
n.a. anymore - The scanner tab card has been removed
from the VB10A application as the functionality is
provided from other vendors. See VB10A User Manual
statement "You can also import images in various
formats (JPEG, BMP, TIFF) into your database, or scan
hard copies with a connected scanner (digitizing)." | Scanned Images
Scanned images can be cropped before saving.
Irreversible cropping of images
• Before saving the images, make sure you will not
need the original images. |
| | Write Lock
The wording was improved for better understanding: | Write Lock
Cancelling write lock on the server workplace manually.
Loss of image modification data
• Before cancelling the write lock, make sure that the
client with write authorization is no longer editing the
images.
• You can find the name of the client with write
authorization in the Host Name column in the Patient
List. |
, - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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| 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 Media | |
| Improper 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 Media | ||
| n.a. anymore - Archival is only allowed on NAS systems; CD/DVD is not intended as archive media | ||
| Displayed Patient Data | ||
| n.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 Data | |
| Text elements are too small. | ||
| Patient information is cut off Note that patient information may not be fully displayed. |
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| Functionality | syngo.plaza VB10A | syngo.plaza VA20A |
|---|---|---|
| Standards | SMPTE - n.a. anymore, syngo.plaza itself does not | |
| comply to the SMPTE standard as the compliance to | ||
| this standard lies within the responsibility to the | ||
| customer. This is communicated via User Manual | ||
| Chapter 2 on page 32 ("Approved calibrated monitors | ||
| are required for diagnostic workstations") and | ||
| ("Monitors that are used for medical reporting must be | ||
| calibrated before use") | SMPTE (Society of Motion Picture and Television | |
| Engineers) Test Pattern [1995] - Intended to test | ||
| CRT monitors and printers used to display medical | ||
| images for acceptance and quality control purposes. | ||
| The conformance to this standard is ensured by | ||
| verification activities as the usage of SMPTE pattern |
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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 Clearance
Number |
|--------------|-----------------------|-------------------------|
| 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
. .
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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:
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.
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
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