(62 days)
Not Found
No
The document describes standard image processing and visualization tools, manual and semi-automatic contouring, and registration techniques. There is no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies described are standard verification and validation tests, not studies typically associated with evaluating AI/ML model performance.
No.
The device is described as an "image visualization, multimodality manipulation and contouring tool" that "helps the preparation and response assessment of treatments," such as radiation therapy, but it does not directly perform treatment or provide therapy itself. It is a tool for planning and assessing.
No
The device is described as a "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." It provides tools for viewing, creating, editing, and exporting contours for treatment planning systems, and is used "prior to dosimetric planning and response assessment in radiation therapy." Its function is to support the "preparation" and "response assessment" of radiation therapy treatments, rather than diagnosing a disease or condition. While it processes medical images, its purpose is for treatment planning and evaluation, not diagnostic interpretation.
Yes
The device is described as "image analysis software" and "software application" with no mention of accompanying hardware components required for its primary function. While it interacts with external systems (imaging modalities, laser system, Treatment Planning System), its core functionality is software-based image processing and manipulation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The syngo via RT Image Suite is described as a software tool for visualizing, manipulating, and contouring medical images (CT, PET, MRI, etc.) for the preparation and assessment of radiation therapy treatments. It works with images acquired from imaging modalities, not directly with specimens from the human body.
- Intended Use: The intended use clearly states its purpose is for image visualization, manipulation, and contouring to aid in treatment preparation and response assessment, specifically in the context of radiation therapy. This is an in-vivo application (working with images of the body), not an in-vitro application (working with specimens outside the body).
Therefore, the syngo via RT Image Suite falls under the category of medical imaging software or radiation therapy planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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. Contours and images 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, 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
Product codes (comma separated list FDA assigned to the subject device)
MUJ, LLZ
Device Description
syngo.via RT Image Suite 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 combine 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.
syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk.
The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.
The following features have been modified:
- Routine Annotation Functionality (modified)
- Contouring Tools (modified)
- Patient Marking (modified)
- Structure Set Management (modified)
- Alignment Tools (modified)
- Dose Evaluation (new)
Mentions image processing
Yes, "digital image processing" is mentioned
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images
Anatomical Site
body, skin, targets and organs-at-risk, tumors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Non clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. The modifications described in this Premarket Notification were supported with verification/validation testing. Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
This submission contains performance data to demonstrate conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
Risk Analysis
The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence
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.
Non-Clinical Testing Summary
Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355
Re: K162370
Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, LLZ Dated: August 12, 2016 Received: August 24, 2016
Dear Ms. Mangum:
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Michael D'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) K162370
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. Contours and images 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, 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CEB 801 Subpart D | Over-The-Counter Use (21 CER 801 Subpart C) |
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510(K) SUMMARY FOR SYNGO.VIA RT IMAGE SUITE
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: August 12, 2016
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
Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
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II. Device Name and Classification
| Product Name: | syngo.via RT Image Suite |
|---|---|
| Propriety Trade Name: | syngo.via RT Image Suite |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.5050 |
| Subsequent CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Subsequent Product Code: | LLZ |
III. Predicate Device
Primary Predicate Device:
| Trade Name: | syngo.via RT Image Suite |
|---|---|
| 510(k) Number: | K151380 |
| Clearance Date: | August 13, 2015 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.5050 |
| Subsequent CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Subsequent Product Code: | LLZ |
| Recall: | There have been no recalls for this device |
Secondary Predicate Device:
| Trade Name: | syngo Dosimetrist Workspace v2.7 |
|---|---|
| 510(k) Number: | K101119 |
| Clearance Date: | October 9, 2010 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.5050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Recall: | 68395 |
IV. Device Description
syngo.via RT Image Suite 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 combine 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.
syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk.
The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.
The following features have been modified:
- Routine Annotation Functionality (modified) ●
- Contouring Tools (modified)
- Patient Marking (modified)
- . Structure Set Management (modified)
5
Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image.
- Alignment Tools (modified)
- Dose Evaluation (new)
V. Indications for Use
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. Contours and images 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 .
VI. Comparison of Technological Characteristics with the Predicate Device
syngo.via RT Image Suite has the same intended use, operating principle as well as the image visualization and manipulation technological characteristics as the predicate devices. Evaluation and post-processing are the technological principles for both the subject and predicate devices. The fundamental features of this subject device are: 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. The indications for use are similar.
6
Using a high-level comparison, the subject and predicate devices are based on the following same technological elements respectively have the following differences:
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison | |
|---|---|---|---|---|
| Feature | syngo.via RT Image | |||
| Suite | syngo.via RT Image | |||
| Suite | syngo Dosimetrist | |||
| Workspace v2.7 | ||||
| Basic | ||||
| Features | Routine Reading | |||
| Functionality; Parallel | ||||
| Image Display; Routine | ||||
| Annotation Functionality | Routine Reading | |||
| Functionality; Parallel | ||||
| Image Display; Routine | ||||
| Annotation Functionality | Routine Reading | |||
| Functionality; Parallel | ||||
| Image Display | Routine Annotation | |||
| Functionality | ||||
| supports now a | ||||
| finding feature | ||||
| Contouring | Routine Contouring; | |||
| Advanced Contouring; | ||||
| Contouring on 4D Image | ||||
| Data; Routine Structure | ||||
| Operations; Duplication | ||||
| of Structures and POIs | Routine Contouring; | |||
| Advanced Contouring; | ||||
| Contouring on 4D Image | ||||
| Data; Routine Structure | ||||
| Operations: Duplication | ||||
| of Structures and POIs | Routine Contouring: | |||
| Advanced Contouring: | ||||
| Routine Structure | ||||
| Operations | Routine & | |||
| Contouring Tools | ||||
| and Contouring on | ||||
| 4D Image Data | ||||
| have been | ||||
| improved | ||||
| Patient | ||||
| Marking | Transmission of POIs of | |||
| type isocenter to an | ||||
| external laser system | n/a | Transmission of POIs of | ||
| type isocenter to an | ||||
| external laser system | New feature in the | |||
| subject device but | ||||
| is similar to the | ||||
| secondary one | ||||
| Alignment | ||||
| Tools | Rigid Alignment and | |||
| Deformable Alignment | Rigid Alignment and | |||
| Deformable Alignment | Rigid Alignment | Rigid and | ||
| Deformable | ||||
| Alignment tools | ||||
| have been | ||||
| improved to | ||||
| provide a better | ||||
| workflow | ||||
| Dose | ||||
| Evaluation | Loading of any existing | |||
| dose files: Addition or | ||||
| Subtraction of two dose | ||||
| files | n/a | n/a | new feature |
Table 4 Differences and Similarities in Technical Characteristics
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
This submission contains performance data to demonstrate conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
Risk Analysis
The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence
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.
Non-Clinical Testing Summary
Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. 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.
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
7
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 following safety and performance standards:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and Date | 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 |
| N/A | Software | Medical device software - Software life
cycle processes | 62304 First edition
2006-05 | 08/20/2012 | IEC |
| 5-40 | General | Medical devices – Application of risk
management to medical devices | 14971 Second
Edition 2007-03-
01 | 06/27/2016 | ISO |
| 5-85 | General | Medical electrical equipment - Part 1-6:
General requirements for basic safety
and essential performance - Collateral
Standard: Usability | 60601-1-6 Edition
3.0 | 07/09/2014 | IEC |
| N/A | General | Medical electrical equipment - Part 1-4:
General requirements for safety -
Collateral standard Programmable
electrical medical systems, Edition 1.1 | 60601-1-4:2000,
Consol. Ed. 1.1 | 09/08/2009 | IEC |
In this subject device six scientific articles are used to support the marketing claims provided in the product brochure.
VIII. Conclusions
The predicate devices were cleared based on non-clinical supportive information. The subject device was tested using the same non-clinical methods. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and Validation testing also demonstrates that syngo.via RT Image Suite performs as intended. The non-clinical test data demonstrates that syngo.via RT Image Suite device performance is comparable to the predicate devices that are currently marketed for the same intended use. Furthermore, for the subject device, syngo.via RT Image Suite, Siemens used the same testing with the same workflows as was used to clear the predicate devices. 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.
In summary, Siemens is of the opinion that the syngo.via RT Image Suite does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.