(17 days)
No
The document describes advanced visualization and image processing tools, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The modifications listed are related to specific imaging techniques and data types, not AI/ML algorithms.
No.
The device is described as providing "advanced visualization tools to prepare and process medical images for diagnostic purpose" and assisting in "analysis of clinical data" for diagnosis, but it does not directly treat or prevent a disease or condition. It is a diagnostic support tool.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides tools "to prepare and process medical images for diagnostic purpose" and that "Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis."
Yes
The device description explicitly states it is a "software bundle" and its function is to provide "advanced visualization tools" and "measurements" on medical images acquired by other modalities. There is no mention of any hardware component being part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that syngo.CT Extended Functionality is a software package that provides advanced visualization and processing tools for medical images acquired from modalities like CT and MR scanners. It works with existing image data, not biological samples.
- Intended Use: The intended use is to "prepare and process medical images for diagnostic purpose" and "assist trained technicians or physicians in diagnosis" based on these images. This is image analysis and post-processing, not in vitro testing.
Therefore, syngo.CT Extended Functionality falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
Product codes
JAK
Device Description
syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. In addition, the table below shows which extensions has been changed in the current software version SOMARIS/8 VB40.
1 Interactive Spectral Imaging (new)
2 Vascular/Vessel Extension (modified)
3 Oncology Extension (modified)
4 Osteo (unmodified)
5 Neuro DSA (unmodified)
6 ROI HU Threshold (unmodified)
7 Dual Energy (unmodified)
8 Endoscopic View (unmodified)
syngo.CT Extended Functionality is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Clinical Extensions (K173625) and includes the following modifications in comparison to the primary predicate device:
- Support of Interactive Spectral Imaging a.
- Vascular Extension modification: b.
- i. 2D Filter Type Support
- ii. Multiphase Support in Vessel Layout
- Oncology Extension modification: C.
- i. Support of MR Data
- General: Multiphase support for merged 4D series d.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technicians and physicians
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
Performance tests were conducted to test the Interactive Spectral Imaging (ISI) functionality of the syngo.CT Extended Functionality post-processing application. A phantom-based validation "Detailed Description and Bench Tests for the Plugin "Interactive Spectral Imaging"" has been conducted to show that the feature ISI operates as intended.
Non-clinical tests and a phantom-based bench test have been conducted to establish the proficiency of the 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)
Performance tests were conducted to test the Interactive Spectral Imaging (ISI) functionality of the syngo.CT Extended Functionality post-processing application. A phantom-based validation "Detailed Description and Bench Tests for the Plugin "Interactive Spectral Imaging"" has been conducted to show that the feature ISI operates as intended.
Non-clinical tests and a phantom-based bench test have been conducted to establish the proficiency of the 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2019
Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K192402
Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 29, 2019 Received: September 3, 2019
Dear Alaine Medio:
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 medical devices and radiation-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
Indications for Use
510(k) Number (if known) K192402
Device Name syngo.CT Extended Functionality
Indications for Use (Describe)
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
| 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
510(K) SUMMARY FOR SYNGO.CT EXTENDED FUNCTIONALITY
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: September 18, 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
Alaine Medio Regulatory Affairs Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865)206-0337 Fax: (865) 218-3019 Email: alaine-medio(@siemens-healthineers.com
Alternate Contact :
Tabitha Estes
II. Device Name and Classification
| Product Name: | syngo.CT Extended Functionality |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
4
III. Predicate Device
Primary Predicate Device:
| Trade Name: | syngo.CT Clinical Extensions |
|---|---|
| 510(k) Number: | K173625 |
| Clearance Date: | 03/08/2018 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | There are currently no recalls for this device |
Secondary Predicate Device:
| Trade Name: | syngo.CT Dual Energy |
|---|---|
| 510(k) Number: | K150757 |
| Clearance Date: | 08/11/2015 |
| Classification Name: | System, Image Processing, Radiological |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | There are currently no recalls for this device |
IV. Device Description
syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. In addition, the table below shows which extensions has been changed in the current software version SOMARIS/8 VB40.
| No | Extension | No | Extension |
|---|---|---|---|
| 1 | Interactive Spectral Imaging (new) | 5 | Neuro DSA (unmodified) |
| 2 | Vascular/Vessel Extension (modified) | 6 | ROI HU Threshold (unmodified) |
| 3 | Oncology Extension (modified) | 7 | Dual Energy (unmodified) |
| 4 | Osteo (unmodified) | 8 | Endoscopic View (unmodified) |
syngo.CT Extended Functionality is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Clinical Extensions (K173625) and includes the following modifications in comparison to the primary predicate device:
- Support of Interactive Spectral Imaging a.
- Vascular Extension modification: b.
- i. 2D Filter Type Support
- ii. Multiphase Support in Vessel Layout
- Oncology Extension modification: C.
- i. Support of MR Data
- General: Multiphase support for merged 4D series d.
5
V. Indications for Use
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
VI. Comparison of Technological Characteristics with the Predicate Device
The indications for use for the syngo.CT Extended Functionality are identical to the predications for Use (see Table 2). The only difference is the renaming of the feature from syngo.CT Clinical Extensions to syngo.CT Extended Functionality. The intended use of this product is identical to the predicates.
| Subject Device | Predicate Device (K173625) | Comparison Result |
|---|---|---|
| syngo.CT Extended Functionality | syngo.CT Clinical Extensions | Identical with the exception |
| of the name of the product. | ||
| syngo.CT Extended Functionality is | ||
| intended to provide advanced visualization | ||
| tools to prepare and process medical | ||
| images for diagnostic purpose. The | ||
| software package is designed to support | ||
| technicians and physicians in qualitative | ||
| and quantitative measurements and in the | ||
| analysis of clinical data that was acquired | ||
| and reconstructed by Computed | ||
| Tomography (CT) scanners, and possibly | ||
| other medical imaging modalities (e.g. MR | ||
| scanners). | ||
| An interface shall enable the connection | ||
| between the syngo.CT Extended | ||
| Functionality software package and the | ||
| interconnected CT Scanner system. | ||
| Result images created with the syngo.CT | ||
| Extended Functionality software package | ||
| can be used to assist trained technicians or | ||
| physicians in diagnosis. | syngo.CT Clinical Extensions is intended | |
| to provide advanced visualization tools to | ||
| prepare and process medical images for | ||
| diagnostic purpose. The software package | ||
| is designed to support technicians and | ||
| physicians in qualitative and quantitative | ||
| measurements and in the analysis of | ||
| clinical data that was acquired and | ||
| reconstructed by Computed Tomography | ||
| (CT) scanners, and possibly other medical | ||
| imaging modalities (e.g. MR scanners). | ||
| An interface shall enable the connection | ||
| between the syngo.CT Clinical | ||
| Extensions software package and the | ||
| interconnected CT Scanner system. | ||
| Result images created with the syngo.CT. | ||
| Clinical Extensions software package can | ||
| be used to assist trained technicians or | ||
| physicians in diagnosis. |
Table 2: Indications for Use / Intended Use Comparison
As with the primary predicate device, the subject device is a bundle software package consisting of previously cleared software applications (unmodified and modified) that provide advanced visualization and measurement tools.
Software version SOMARIS/8 VB40 supports additional post-processing application features for MR datasets, dual energy images, and endoscopic visualization tools. At a high-level, the subject and predicate devices are based on the following same or similar technological characteristics as listed in Table 3 below:
6
| Table 3: Technological Characteristic Comparison | |||
|---|---|---|---|
| -- | -- | --------------------------------------------------- | -- |
| Feature | Subject Device | Predicate Device
and Supported Functionality | Comparison Result |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | yngo.CT Extended Functionality | | |
| Software
Version | SOMARIS/8 VB40 | Primary Predicate Device:
K173625, clearance date 03/08/2018
SOMARIS/8 VB30 | Modified to
support additional
functionality |
| | 1. Interactive Spectral Imaging | | |
| Interactive
Spectral
Imaging | The Interactive Spectral Imaging
functionality allows the user to display
different representations of Dual
Energy data with an interactive image
text. | Secondary Predicate Device
K150757, clearance date 08/11/2015
The user can change the visualization
of Dual Energy data generated from
Low and High data to different Dual
Energy types. | This feature is
new in the subject
device, but the
fundamental
technology has
been cleared with
the secondary
predicate device. |
| | 2. Vascular/Vessel Extension | | |
| Vascular/
Vessel
Extension | The Vascular Tool provides tools and
layouts for vascular assessment.
Additionally, the subject device
Vascular Tool provides a 2D Filter
Type Support and Multiphase Support
in Vessel Layout. | Primary Predicate Device:
K173625, clearance date 03/08/2018
The Vascular Tool provides tools and
layouts for vascular assessment and
CT data. | This modification
is a usability
improvement. |
| | 3. Oncology Extension | | |
| Oncology
Extension | The oncology Tool offers tools for
localization and evaluation of nodules.
Additionally, the subject device now
provides MR Support for Diameter
WHO. | Primary Predicate Device:
K173625, clearance date 03/08/2018
The oncology extension offers tools
for localization and evaluation of
nodules. | Modified to
support MR data
for Diameter
WHO. |
| | 4. Osteo Extension | | |
| Osteo
Extension | The Osteo extension is used for the
evaluation of Bone Mineral Density
(BMD) values (mg CA-HA/ml) of the
lumbar spine based on Osteo CT scans. | Primary Predicate Device:
K173625, clearance date 03/08/2018
The Osteo extension is used for the
evaluation of Bone Mineral Density
(BMD) values (mg CA-HA/ml) of the
lumbar spine based on Osteo CT
scans. | Same – There are
no modifications. |
| | 5. Neuro DSA Extension | | |
| Neuro DSA
Extension | Bone removal tool from a CT
angiography dataset. | Primary Predicate Device:
K173625, clearance date 03/08/2018
Bone removal tool from a CT
angiography dataset. | Same – There are
no modifications. |
| | 6. Dual Energy ROI | | |
| Dual
Energy ROI | Evaluation of low/high kV images from
dual energy data. | Primary Predicate Device:
K173625, clearance date 03/08/2018
Evaluation of low/high kV images
from dual energy data. | Same – There are
no modifications. |
| 7. Endoscopic View | | | |
| Endoscopic
View Tool | Fly through tubular structures which
are either filled by low-intensity (e.g.
air-filled) or high-intensity (e.g. blood-
filled) material. | Primary Predicate Device:
K173625, clearance date 03/08/2018
Fly through tubular structures which
are either filled by low-intensity (e.g.
air-filled) or high-intensity (e.g.
blood-filled) material. | Same – There are
no modifications. |
7
| Feature | Subject Device
syngo.CT Extended Functionality | Predicate Device
and Supported Functionality | Comparison
Result |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 8. ROI HU Threshold | | | |
| ROI HU
Threshold | Evaluation of HU value distributions
within a user defined region of interest. | Primary Predicate Device:
K173625, clearance date 03/08/2018
Evaluation of HU value distributions
within a user defined region of
interest | Same – There are
no modifications. |
| General, Extension-independent Functionality | | | |
| Pre-
generated
results | Support of pre-generated results and the
ability to edit pre-generated results | Primary Predicate Device:
K173625, clearance date 03/08/2018
Support of pre-generated results and
the ability to edit pre-generated
results | Same – There are
no modifications. |
| | | | |
| Multiphase
support for
merged 4D
series | Grouping of multiphase series
generated by respiratory gated,
perfusion and cardiac datasets. | Primary Predicate Device:
K173625, clearance date 03/08/2018
Grouping of multiphase series
generated by respiratory gated and
perfusion datasets. | Usability
improvement: The
grouping logic has
been extended to
include cardiac
gated datasets. |
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device, syngo.CT Extended Functionality are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.
VII. Performance Data
Software Verification and Validation Testing
Software Documentation for a Moderate 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 included as part of this submission.
Non-Clinical / Clinical Testing Summary
syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and 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 | 12/23/2016 | IEC |
Performance tests were conducted to test the Interactive Spectral Imaging (ISI) functionality of the syngo.CT Extended Functionality post-processing application. A phantom-based validation "Detailed Description and Bench
8
Tests for the Plugin "Interactive Spectral Imaging"" has been conducted to show that the feature ISI operates as intended.
Non-clinical tests and a phantom-based bench test have been conducted to establish the proficiency of the 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 used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing.
VIII. Conclusions
syngo.CT Extended Functionality has the same indication for use as the primary predicate device. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate devices. For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Extended Functionality to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices.