(51 days)
Not Found
No
The document describes a standard PACS system with image processing capabilities and integration with HIS/RIS, but there is no mention of AI, ML, or related terms. The performance studies section also indicates non-clinical testing, which is less common for devices relying heavily on AI/ML for diagnostic interpretation.
No
Explanation: The device is intended for displaying, processing, and archiving medical images to support diagnosis and treatment planning, not to directly treat a disease or condition.
No.
The intended use states it "supports the physician in diagnosis and treatment planning," but it is a PACS system for displaying and managing images. The performance studies show no clinical studies were carried out. While it processes images and is used in a diagnostic setting, it is not described as performing the diagnosis itself.
Yes
The device description explicitly states "syngo®.plaza is a 'software only'-system". While it requires common IT hardware for installation, the device itself, as described, is solely the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that syngo .plaza is a Picture Archiving and Communication System (PACS) used for displaying, processing, reading, reporting, communicating, distributing, storing, and archiving digital images. It supports physicians in diagnosis and treatment planning based on these images.
- 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.
- Nature of the Device: syngo .plaza is a software system that works with medical images. It does not perform any tests on biological samples.
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 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
Product codes
LLZ
Device Description
syngo®.plaza is a "software only"-system, to be installed on common IT hardware, matching the syngo®.plaza hardware requirements.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, Ultrasound and X-Ray
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)
No clinical studies were carried out for syngo®.plaza, all performance testing was conducted in a non-clinical fashion as part of the verification and validation activities fir the medical device
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized image of a human figure.
April 25, 2018
Siemens Healthcare GmbH % Mr. Alexander Schapovalov Responsible Third Party Official 510(k) TPR Deputv Program Manager TÜV SÜD America Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891
Re: K180563
Trade/Device Name: syngo®.plaza Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 11, 2018 Received: April 16, 2018
Dear Mr. Schapovalov:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Mr. Schapovalov
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in all caps on the top line, and the word "Healthineers" is written on the second line. To the right of the words is a graphic of several small circles.
Traditional 510(k) Summary
syngo®.plaza VB30
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Submitter
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
2. Establishment Registration Number
3002808157
3. Contact Person
Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH Hartmanstrasse 16 91052 Erlangen Germany Telephone: +49 172 432 4369 +49 (9131) 84-8691 Telefax: Email: vijay.ramadas@siemens-healthineers.com
4. Device Name and Classification
Product Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
syngo®.plaza Picture Archiving and Communications System Radiology 21 CFR §892.2050 Class II LLZ
5. Legally Marketed Predicate Device
| Product Name: | syngo®.plaza |
|---|---|
| 510(k) Number: | K132532 |
| Clearance Date | December 09, 2013 |
6. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
6.1 Intended Use
syngo@.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning
For primary image diagnosis in Mammography only uncompressed or nonlossy compressed images and only preprocessed DICOM "For Presentation"
4
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)
5
്പുഴു
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 not intended for reporting ”, because the reporting was enabled in Web Client in VB30 when compared to the predicate device VB10A. This change was achieved by extending the reporting functionality from Reporting Client to Web Client and this is not a new functionality | This update does not impact or change the safety and effective use of the product |
| syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact | |
| used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo®.plaza also supports DICOM Structured Reports. | used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo®.plaza also supports DICOM Structured Reports. | |||
| In a comprehensive imaging suite, syngo®.plaza integrates Hospital / Radiological Information Systems (HIS / RIS) to enable customer specific workflows. | In a comprehensive imaging suite, syngo®.plaza integrates Hospital / Radiological Information Systems (HIS / RIS) to enable customer specific workflows. | |||
| syngo®.plaza optionally uses a variety of advanced postprocessing applications. | syngo®.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting. | |||
| Supported Modalities | CT, MR, Ultrasound and X-Ray | CT, MR, Ultrasound and X-Ray | Same | NA |
| Image Communication | Standard network protocols like TCP / IP and standard communication protocol | Standard network protocols like TCP / IP and standard communication protocol | Same | NA |
| syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact | |
| Image data compression | DICOM. Additional fast image transfer protocol for use inside syngoⓇ.plaza | |||
| 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 | DICOM. Additional fast image transfer protocol for use inside syngoⓇ.plaza
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 | 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
Processing | Tomosynthesis
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-
sing
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- | 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- | Same | NA |
| syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact | |
| Reference) (calculated: Coordinates of the projected points from one plane on other orthogonal planes) | Reference) (calculated: Coordinates of the projected points from one plane on other orthogonal planes) | | | |
| Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values | Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values | | | |
| (calculated: Statistical values based on image pixel intensity in a given ROI) | (calculated: Statistical values based on image pixel intensity in a given ROI) | | | |
| Affine Transformation (Zoom/Pan/Rotate/Flip) | Affine Transformation (Zoom/Pan/Rotate/Flip) | | | |
| (calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation) | (calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation) | | | |
| In syngo.plaza 2D Image processing Library Region Calculation (Mammography) | In syngo.plaza 2D Image processing Library Region Calculation (Mammography) | | | |
| (calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity) | (calculated: Minimum bounding Rect co-ordinates of the tissue area in an image based on pixel intensity) | | | |
| syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact | |
| 3D Projection (Cross-
Reference) (calculated: Co-ordinates of the projected points from one plane on other orthogonal planes)
Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values | 3D Projection (Cross-
Reference) (calculated: Co-ordinates of the projected points from one plane on other orthogonal planes)
Statistical Algorithms for calculation of Average, Std Deviation, Minimum or Maximum pixel values | | | |
| (calculated: Statistical values based on image pixel intensity in a given ROI)
Affine Transformation (Zoom/Pan/Rotate/Flip)
(calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation) | (calculated: Statistical values based on image pixel intensity in a given ROI)
Affine Transformation (Zoom/Pan/Rotate/Flip)
(calculated: New position of the given point (x,y) of image in displayed window after performing any of the affine operation) | | | |
| Distance: Line Measurement between 2 points, calculation based on image pixel spacing value and the length of the line between start and end points
Angle: The angle between the two lines measured in | Distance: Line Measurement between 2 points, calculation based on image pixel spacing value and the length of the line between start and end points
Angle: The angle between the two lines measured in | | | |
| syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact | |
| anti-clockwise direction
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.
Volume: no volume
measurements in syngo.plaza | anti-clockwise direction
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.
Volume: no volume
measurements in syngo.plaza | | | |
| Rendering Algorithm
In 3D application by Voxar
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) | Rendering Algorithm
In 3D application by Voxar
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) | | | |
| | syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact |
| | Volume Rendering
Technique (calculated:
Visualization of 3D volume)
Shaded Surface Display
(calculated: Visualization of
Surface rendered 3D volume)
In syngo.plaza 2D Image
processing Library
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) | Volume Rendering
Technique (calculated:
Visualization of 3D volume)
Shaded Surface Display
(calculated: Visualization of
Surface rendered 3D volume)
In syngo.plaza 2D Image
processing Library
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) | | |
| | syngo®.plaza VB30 | syngo®.plaza VB10A | Similarities and Differences Description | Safety and Effectiveness Impact |
| | 24- bit colour Image display using Windows GDI
(calculated: Rendered pixel intensity on the screen co-ordinates)
Windowing and 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) | 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) | Same | NA |
| Cyber Security | Login with encryption
Recommended Virus
Scanners
Software Blacklist
System Hardening | Login with encryption
Recommended Virus
Scanners
Software Blacklist
System Hardening | | |
| Web Client | Improved: Web Client now allows the users to edit and save, thus reporting is made | Web client is not intended to be used for Reporting.
Reporting is available ONLY | The updates are made to provide more options to the end user. The improvement | This update does not impact or change the safety and effective use of the product |
510(k) for syngo®.plaza
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©Siemens Healthcare GmbH, 2018 |
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| syngo®.plaza VB30 | Similarities and Differences
Description | Safety and Effectiveness
Impact |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| reporting functionality is
same as in the existing
Reporting Client | Mitigations were
implemented and verified.
The Risks Mitigations are
same as the existing
Reporting Client | NA |
| syngo®.plaza VB10A | It is a pure post-processing
software and has No
influence | NA |
| None | None | NA |
| None | No CAD functionalities in
the product | NA |
ﺃﺣﺪ ﺍ
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Clinical Testing 8.
No clinical studies were carried out for syngo®.plaza, all performance testing was conducted in a non-clinical fashion as part of the verification and validation activities fir the medical device
9. Non-Clinical Performance Testing
The software verification and validation was performed for the complete system according the following standards:
- ISO 14971:2007 。
- IEC 62304 Edition 1.1 2015-06 -
- IEC 82304-1 Edition 1.1 2016-10 -
- IEC 62366-1 Edition 1.0 2015-02 -
- NEMA PS3 / ISO 12052:2017 (DICOM) -
- ISO / IEC 10918-1:1994 + TC 1:2005 -
- ISO / IEC 15444-1:2005 + TC 1:2007 =
- -IEEE 3333.2.1:2015
- ISO / HL7 21731:2014 (HL7 Version 2.x) -
After comparison of the test results with the software release acceptance criteria, Siemens Healthcare GmbH is of the opinion, that syngo@.plaza VB30 is substantially equivalent to and performs as well as the predicate device syngo®.plaza VB10A
10. General Safety and Effectiveness Information
The device labeling contains instructions for use and necessary cautions for safe and effective use of the device. Risk Management was implemented throughout the development process to control potential hazards
The device does not come into contact with the patient and is only used by trained professionals. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation
Siemens Healthcare GmbH believes that syngo®.plaza VB30 is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns
11. Substantial Equivalence
The syngo®.plaza, addressed in this premarket notification, is substantially equivalent to the following commercially available device:
| Manufacturer | Predicate Device | FDA Clearance Number | Clearance Date |
|---|---|---|---|
| Siemens AG Healthcare | syngo®.plaza VB10A | K132532 | December 09, 2013 |
The syngo®.plaza described in this 510(k) has the same intended use and similar technical characteristics as the predicate device listed above in regard to the specific functionalities.
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12. Conclusion
In summary, Siemens Healthcare GmbH is of the opinion that syngo®.plaza VB30 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.