(48 days)
Yes
The summary explicitly states, "A new deep learning-based approach that uses an adversarial network has been implemented" and mentions a "Deep Image-to-Image Network performing organ segmentation," which are forms of AI/ML.
No
The device is a software tool for image visualization, manipulation, and contouring, primarily used for treatment preparation and response assessment in radiation therapy, rather than directly providing a therapeutic effect. It aids in planning and assessment but does not administer treatment itself.
No.
The device is described as an image visualization, manipulation, and contouring tool used for the preparation and response assessment of treatments, primarily in radiation therapy. It provides tools for viewing, creating, editing, and modifying contours of the body and simple treatment plans. While it aids in treatment planning and assessment, it does not explicitly state that it diagnoses medical conditions or makes a definitive medical diagnosis itself. Its function is to assist in the preparation and assessment of treatments, which are distinct from making a diagnosis.
Yes
The device description explicitly states it is "an image analysis software" and details various software functionalities for viewing, manipulating, and analyzing medical images. There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a tool for image visualization, manipulation, and contouring to aid in the preparation and response assessment of treatments like radiation therapy. It focuses on processing medical images and creating anatomical contours.
- Device Description: The device description reinforces this by stating it's an image analysis software for viewing, manipulation, visualization, comparison, and segmentation of medical images prior to dosimetric planning and response assessment in radiation therapy.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens. Its function is solely based on processing medical images.
The device is a medical image processing and analysis software used in the field of radiation oncology, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The “Control Plan Authorized (PCCP) and relevant text” section explicitly states “Not Found.”
Intended Use / Indications for Use
syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).
It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines following digital image processing and visualization tools:
- Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
- Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
- Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- Creation of contours on any type of images without prior assignment of a planning CT.
- Manual and semi-automatic registration using rigid and deformable registration
- Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
- Supports the user in comparing images and contours of different patients
- Supports multi-modality image fusion
- Visualization and contouring of moving tumors and organs
- Management of points of interest including but not limited to the isocenter
- Management of simple treatment plans
- Generation of a synthetic CT based on multiple pre-define MR acquisitions
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
The subject device with the current software version SOMARIS/8 VB40 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. At a high-level, the following features have been modified:
-
- Beam Placement
- Reference Point Management 2.
-
- Patient Marking
-
- Contouring
-
- Structure Set Management
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
Anatomical Site
Body (skin outline, targets and organs-at-risk), pelvic and head/neck regions, thoracic and abdominal regions, OAR Brain, Liver, Kidney Left, Kidney Right, Femur Head Right, Heart, Prostate and Rectum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professional. Not Found for care setting.
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
The organ-at-risk (OAR) segmentation of the subject device consists of a region of interest detection based on anatomical landmarks, followed by a Deep Image-to-Image Network performing organ segmentation. Those both parts of the segmentation algorithm were validated separately using a testing set of 32 datasets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation: Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.
Non-Clinical Testing: Non-clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Clinical Testing: The results of the evaluation show improved performance of the subject device syngo.via RT Image Suite (software version SOMARIS/8 VB40), compared to the predicate device syngo.via RT Image Suite (software version SOMARIS/8 VB30). The detailed report is provided in support of the device modifications.
The organ-at-risk (OAR) segmentation of the subject device consists of a region of interest detection based on anatomical landmarks, followed by a Deep Image-to-Image Network performing organ segmentation. Those both parts of the segmentation algorithm were validated separately using a testing set of 32 datasets.
The detection rate of the subject device improved for the OAR Brain, Liver, Kidney Left, and Kidney Right compared to the predicate device, achieving 100% for all evaluated organs.
The segmentation quality was assessed by comparing a manually annotated ground truth with the algorithm result using the distance measure Average Symmetric Surface (ASSD) and the overlap measure DICE coefficient. The mean ASSD computed for the subject device ranged between 0.64 mm (for Femur Head Right) and 3.04 mm (for Heart) and improved for all evaluated OAR. The mean DICE coefficient ranged between 0.85 (for Prostate and Rectum) and 0.97 (for Heart). The results for mean ASSD and mean DICE coefficient both demonstrate the improved segmentation quality provided by the subject device compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detection rate: 100% for OAR Brain, Liver, Kidney Left, Kidney Right.
Mean Average Symmetric Surface (ASSD): ranged between 0.64 mm (for Femur Head Right) and 3.04 mm (for Heart).
Mean DICE coefficient: ranged between 0.85 (for Prostate and Rectum) and 0.97 (for Heart).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
September 18, 2019
Siemens Medical Solutions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 2501 N Barrington Road HOFFMAN ESTATES IL 60192
Re: K192065
Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: July 31, 2019 Received: August 1, 2019
Dear Ms. Padharia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K192065
Device Name syngo.via RT Image Suite
Indications for Use (Describe)
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).
It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatmently be exported to a Treatment Planning System.
The software combines following digital image processing and visualization tools:
· Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT. PET. PET/CT. MRI. Linac Cone Beam CT (CBCT) images and dose distributions
· Multiplanar reconstruction (MPR) thick, minimum intensity projection (MIP), volume rendering technique (VRT)
- · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- · Creation of contours on any type of images without prior assignment of a planning CT
· Manual and semi-automatic registration using rigid and deformable registration
· Supports the user in comparing, and adapting contours based on datasets acquired with different imaging modalities and at different time points
· Supports the user in comparing images and contours of different patients
- · Supports multi-modality image fusion
- · Visualization and contouring of moving tumors and organs
- · Management of points of interest including but not limited to the isocenter
- · Management of simple treatment plans
- · Generation of a synthetic CT based on multiple pre-define MR acquisitions
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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FORM FDA 3881 (7/17)
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3
510(K) SUMMARY FOR
SYNGO.VIA RT IMAGE SUITE
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: June 25, 2019
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.
I. Submitter
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany
Establishment Registration Number 3004977335
Contact Person
Veronica Padharia Regulatory Affairs Specialist, CNMT Siemens Medical Solutions, Inc. USA 2501 N. Barrington Road Hoffman Estates, IL 60192 Phone: (630) 877-5761 Fax: (847) 304-6023 email: veronica.padharia(@siemens-healthineers.com
II. Device Name and Classification
Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
syngo.via RT Image Suite syngo.via RT Image Suite System, Planning, Radiation Therapy Treatment Radiology 21 CFR §892.5050 Class II MUJ
III. Predicate Device
- Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section:
syngo.via RT Image Suite K173635 01/12/2018 System, Planning, Radiation Therapy Treatment Radiology 21 CFR §892.5050
4
Device Class: Class II Product Code: MUJ Recall Information:
There have been no recalls for this device
IV. Device Description
The subject device with the current software version SOMARIS/8 VB40 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. At a high-level, the following features have been modified:
-
- Beam Placement
- Reference Point Management 2.
-
- Patient Marking
-
- Contouring
-
- Structure Set Management
V. Indications for Use
syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).
It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines following digital image processing and visualization tools:
- . Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
- Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
- Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- Creation of contours on any type of images without prior assignment of a planning CT .
- Manual and semi-automatic registration using rigid and deformable registration ●
- Supports the user in comparing, contouring, and adapting contours based on datasets acquired ● with different imaging modalities and at different time points
- . Supports the user in comparing images and contours of different patients
- Supports multi-modality image fusion ●
- Visualization and contouring of moving tumors and organs ●
- Management of points of interest including but not limited to the isocenter
- Management of simple treatment plans
- Generation of a synthetic CT based on multiple pre-define MR acquisitions ●
5
SIEMENS
VI. Comparison of Technological Characteristics with the Predicate Device
As with the predicate device, the subject device supports viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy.
At a high-level a tabular summary of the subject and predicate device's technological differences is provided as Table 4 below for the software version SOMARIS/8 VB40:
| Feature | Comparison of the Subject Device to the Predicate Device |
|---|---|
| Beam | |
| Placement | Creation of new geometric treatment plans for photon radiotherapy. The syngo.via workflow |
| supports a more user intuitive workflow (i.e. a more modern look and feel). |
Modification: Beam placement auto shape now also allows in creating rectangular block
fields. |
| Reference
Point
Management | Reference Point Management allows the user to edit the position, color, and type of Points of
Interest (POI).
Modification: The workflow for reference point creation has been simplified and a
streamlined workflow for breast iso-centering has been implemented. |
| Patient
Marking | Sending of reference points with offset details to a laser system.
Modification: Support of simplified workflow for breast iso-centering. Enabled by combining
improvements in iso-centering contouring the breast. It identifies the breast boundaries and
suggests a proper iso-center for breast treatment. |
| Routine
Contouring | Routine Contouring tools (e. g. freehand drawing tools, creation of margins etc.)
Modifications include capability of interpolating contours, 3D Pan/Scale options, and option
to add rectangular and ellipse as contour shapes, improvement in nudge tool to enable auto
filling of the inner part of a closed contour, and restricting the margin extension to external
contour. |
| Advanced
Contouring | Advanced Contouring tools (automatic contouring of different structures, nudge 3D tool,
contour interpolation etc.). Automatic contouring of pelvic and head/neck regions, support of
Rapid Results Technology.
Modification: This subject device provides the following extensions:
• Automatic Contouring can be applied on further structures (thoracic and abdominal
regions)
• A new deep learning-based approach that uses an adversarial network has been
implemented |
| Structure Set
Management | The Structure Set Management provides the following functionality:
• Loading and storing of DICOM RT structure sets, creating, editing and deletion of
structures and POIs.
• Creating, editing and deletion of structure templates.
• Customize predefined structure database with mapping to international nomenclature
schemes.
Modification includes simplifying the user interface. |
Table 1 Differences in Technical Characteristics
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation
Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.
6
SIEMEN
Non-Clinical Testing Summary
Non-clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Clinical Testing Summary
The results of the evaluation show improved performance of the subject device syngo.via RT Image Suite (software version SOMARIS/8 VB40), compared to the predicate device syngo.via RT Image Suite (software version SOMARIS/8 VB30). The detailed report is provided in support of the device modifications.
The organ-at-risk (OAR) segmentation of the subject device consists of a region of interest detection based on anatomical landmarks, followed by a Deep Image-to-Image Network performing organ segmentation. Those both parts of the segmentation algorithm were validated separately using a testing set of 32 datasets.
The detection rate of the subject device improved for the OAR Brain, Liver, Kidney Left, and Kidney Right compared to the predicate device, achieving 100% for all evaluated organs.
The segmentation quality was assessed by comparing a manually annotated ground truth with the algorithm result using the distance measure Average Symmetric Surface (ASSD) and the overlap measure DICE coefficient. The mean ASSD computed for the subject device ranged between 0.64 mm (for Femur Head Right) and 3.04 mm (for Heart) and improved for all evaluated OAR. The mean DICE coefficient ranged between 0.85 (for Prostate and Rectum) and 0.97 (for Heart). The results for mean ASSD and mean DICE coefficient both demonstrate the improved segmentation quality provided by the subject device compared to the predicate device.
Standards
Siemens claims conformance to the following performance standards:
| Recognition
Number | Product
Area | Title of Standard | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software -Software Life
Cycle Processes; 62304:2006 (1st Edition) | 08/20/2012 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 08/20/2012 | ISO |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 06/27/2016 | IEC |
Summary
This subject device provides tools designed help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk. The fundamental software technology which is provided within the scope of the subject device is already cleared and remains unchanged in comparison to the predicate device. The Indications for Use for the subject device remains unchanged. The modifications described in this Premarket Notification were supported with verification and validation testing and clinical performance evaluation. The Risk analysis was completed and risk control implemented to mitigate identified hazards.
7
SIEMENS
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. syngo.via RT Image Suite is designed to fulfill the requirements of the applicable safety and performance standards as listed above.
VIII. Conclusions
The predicate device was cleared based on non-clinical testing including verification and validation, phantom tests, and supportive literature. The results of these tests demonstrate that the predicate device is adequate for the intended use. The subject device is also tested using the same methods as used for the predicate devices. The comparison of technological characteristics, non-clinical performance data, and software validation included in this submission demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.via RT Image Suite testing supports a finding of substantial equivalence.