(144 days)
No
The document describes standard image rendering and post-processing software without mentioning AI, ML, or related concepts. The performance studies focus on verification and validation of software functionality and risk analysis, not on training or testing of AI/ML models.
No
The device is indicated for image rendering and post-processing of DICOM images to support interpretation, not for treatment or therapy.
Yes
The device is indicated for "image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology," which is a diagnostic purpose. It supports tasks like "reading images and support reporting," further indicating its role in diagnosis.
Yes
The device description explicitly states "syngo.via View&GO is a software-only medical device". It also clarifies that the hardware it runs on is not considered part of the medical device and is not within the scope of the 510(k) submission.
Based on the provided information, syngo.via View&GO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for image rendering and post-processing of medical images (CT, MR, NM, XA, US, DX) to support interpretation in radiology, nuclear medicine, and cardiology. This involves processing images generated from the patient, not analyzing samples from the patient (like blood, urine, or tissue).
- Device Description: The device is described as software for viewing and processing DICOM images. It interfaces with imaging modalities and PACS systems. This aligns with medical image processing software, not IVD devices.
- No mention of analyzing biological samples: The entire description focuses on image data and its manipulation. There is no mention of analyzing biological specimens or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. syngo.via View&GO does not fit this definition.
N/A
Intended Use / Indications for Use
syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA30A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via View&GO, software version VA20A.
syngo.via View&GO is a software-only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via View&GO and therefore not in the scope of this 510(k) submission.
syngo.via View&GO provides tools and features to cover the radiological tasks preparation for reading, reading images and support reporting. syngo.via View&GO supports DICOM formatted images and objects.
syngo.via View&GO is a standalone viewing and reading workplace. This is capable of rendering the data from the connected modalities for the post processing activities. syngo.via View&GO provides the user interface for interactive image viewing and processing with a limited short-term storage which can be interfaced with any Long-term storage (e.g. PACS) via DICOM syngo.via View&GO is based on Microsoft Windows operating systems.
syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.
The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device. syngo.via View&GO, software version VA30A, as well as the predicate device, syngo.via View&GO, software version VA20A.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found. The device uses algorithms for image processing but does not explicitly state the use of AI, DNN, or ML.
Input Imaging Modality
CT Image (Computed Tomography)
MR Image (Magnetic Resonance)
NM Image (Nuclear Medicine)
XA Image (X-Ray Angiography)
US Image (Ultrasound)
DX Image (Digital Radiography)
DICOM secondary capture objects
Anatomical Site
Not Found.
Indicated Patient Age Range
syngo.via View&GO has neither limitations concerning the patient population (e.g. age, weight, health, condition) nor limitations concerning region of body or tissue type.
Intended User / Care Setting
healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
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 were conducted for the device syngo.via View&GO during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the device syngo.via View&GO during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Performance tests were conducted to test the functionality of the device syngo.via View&GO. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting 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.
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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, 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.
Siemens Healthcare GmBH Frederike Jakob Regulatory Affairs Manager Siemensstraße 1, Forchheim Erlangen, Bavaria Germany
Re: K221501
October 14, 2022
Trade/Device Name: syngo.via View&GO Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 14, 2022 Received: September 15, 2022
Dear Frederike Jakob:
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,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221501
Device Name syngo.via View&GO VA30A
Indications for Use (Describe)
syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology.
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
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.
Date prepared: June 29, 2022
-
- Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
Establishment Registration Number: 3004977335
- Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
2. Contact Person:
Ms. Frederike Jakob Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: Frederike.Jakob(@siemens-healthineers.com Telephone: +49 (0)162 109 2694 Fax: +49 (9191) 18-4404
3. Device Name and Classification:
| Trade Name: | syngo.via View&GO (Version VA30A) |
|---|---|
| Classification Name: | Medical Image Management and Processing System (PACS) |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
4. Legally Marketed Predicate Device:
| Trade Name: | syngo.via View&GO (Version VA20A) |
|---|---|
| 510(k) Clearance: | K201477 |
| Clearance Date: | July 1, 2020 |
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Recall Information: | This predicate device has not been the subject of any |
| design related recalls. |
4
5. Device Description:
Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA30A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via View&GO, software version VA20A.
syngo.via View&GO is a software-only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via View&GO and therefore not in the scope of this 510(k) submission.
syngo.via View&GO provides tools and features to cover the radiological tasks preparation for reading, reading images and support reporting. syngo.via View&GO supports DICOM formatted images and objects.
syngo.via View&GO is a standalone viewing and reading workplace. This is capable of rendering the data from the connected modalities for the post processing activities. syngo.via View&GO provides the user interface for interactive image viewing and processing with a limited short-term storage which can be interfaced with any Long-term storage (e.g. PACS) via DICOM syngo.via View&GO is based on Microsoft Windows operating systems.
syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.
The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device. syngo.via View&GO, software version VA30A, as well as the predicate device, syngo.via View&GO, software version VA20A.
6. Intended Purpose:
6.1 Intended Use
syngo.via View&GO is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.
syngo.via View&GO supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
The subject device and the predicate device share an identical intended use.
5
6.2 Indications for Use
syngo.via View&GO is indicated for image rendering and post-processing of DICOM images to support the interpretation in the field of radiology, nuclear medicine and cardiology.
The subject device and the predicate device share identical indications for use. The indications for use fall within the scope of the intended use.
6.3 Contraindications
The system is not indicated for mammography images for diagnosis in the U.S. The application is not to be used as an archiving device for patients' image data. The application is not to be used as a sole basis for clinical decisions but further evidence has to be taken into account.
The subject device and the predicate device share substantially identical contraindications.
6.4 Patient Target Population
syngo.via View&GO has neither limitations concerning the patient population (e.g. age, weight, health, condition) nor limitations concerning region of body or tissue type.
The patient target population is identical for the subject device and the predicate device.
6
7. Summary of Differences between the Subject Device and the Predicate Device:
The following table compares the functionality of syngo.via View&GO VA30A to the predicate device syngo.via View&GO VA20A:
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name
and version (K
number) | syngo.via View&GO
(Version VA30A) | syngo.via View&GO
Version VA20A
(K201477) | New product
version | NA |
| Manufacturer | Siemens Healthcare
GmbH | Siemens Healthcare
GmbH | Identical | NA |
| Intended use | syngo.via View&GO is
a software solution
intended to be used for
viewing, manipulation,
communication, and
storage of medical
images.
It can be used as a
stand-alone device or
together with a variety
of cleared and
unmodified syngo based
software options.
syngo.via View&GO
supports interpretation
and evaluation of
examinations within
healthcare institutions,
for example, in
Radiology, Nuclear
Medicine and
Cardiology
environments.
The system is not
intended for the
displaying of digital
mammography images
for diagnosis in the U.S. | syngo.via View&GO is
a software solution
intended to be used for
viewing, manipulation,
communication, and
storage of medical
images.
It can be used as a
stand-alone device or
together with a variety
of cleared and
unmodified syngo based
software options.
syngo.via View&GO
supports interpretation
and evaluation of
examinations within
healthcare institutions,
for example, in
Radiology, Nuclear
Medicine and
Cardiology
environments.
The system is not
intended for the
displaying of digital
mammography images
for diagnosis in the U.S. | Identical | NA |
| Software
architecture | Standalone workplace
system that is logically
broken down to
syngo.via View&GO
subsystems.
Subsystems are further
broken down to syngo
software options. | Standalone workplace
system that is logically
broken down to
syngo.via View&GO
subsystems.
Subsystems are further
broken down to syngo
software options. | Identical | NA |
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
| Image
communication | Standard network
protocols like TCP/IP
and standard
communication
protocol DICOM. | Standard network
protocols like TCP/IP
and standard
communication
protocol DICOM. | Identical | NA |
| Imaging
algorithms | - Multiplanar
reconstruction
(MPR)
- Maximum and
Minimum Intensity
Projection
(MIP/MinIP) - Volume Rendering
Technique (VRT)
with additional
edge and surface
enhancements and
control over
rendering
parameters - Shaded Surface
Display (SSD) - Digitally
Reconstructed - Radiograph
- Editor functionality
(e.g. ClipBox) - Registration
- Anatomical
registration - Region growing
- Automatic Spine
Labeling, also for
ribs in CT thorax
scans 1 - Reprocessing X-
ray projection
images into 3D
image and
Topograms 15 - FASTAlign | - Multiplanar
reconstruction
(MPR) - Maximum and
Minimum Intensity
Projection
(MIP/MinIP) - Volume Rendering
Technique (VRT)
with additional
edge and surface
enhancements and
control over
rendering
parameters - Shaded Surface
Display (SSD) - Digitally
Reconstructed - Radiograph
- Editor functionality
(e.g. ClipBox) - Registration
- Anatomical
registration - Region growing
- Automatic Spine
Labeling, also for
ribs in CT thorax
scans 2 (“Rib
labeling”) - Reprocessing X-
ray projection
images into 3D
image and
Topograms 16 | Similar:
Algorithms
underwent
bug-fixing and
minor
improvements
. No re-
training or
change in
algorithm
models was
performed. | The changes
between the
predicate device
and the subject
device doesn't
impact the safety
and effectiveness
of the subject
device as the
necessary
measures were
taken for the
safety and
effectiveness of
the subject
device |
| Quantitative
algorithms | Distance, angle &
angle-on-stack, VOI and
ROI measurements | Distance, angle, VOI
and ROI measurements | Angle-Tool
was extended
with Angle- | The changes
between the
predicate device
and the subject |
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
| | | | on-Stack
functionality | device doesn't
impact the safety
and effectiveness
of the subject
device as the
necessary
measures were
taken for the
safety and
effectiveness of
the subject
device |
| Supported Image
Generating
Modalities | The following Image
types are supported by
syngo.via View&GO: - CT Image
(Computed
Tomography) - MR Image
(Magnetic
Resonance) - NM Image
(Nuclear Medicine) - XA Image (X-Ray
Angiography) - US Image
(Ultrasound) - DX Image (Digital
Radiography) - DICOM secondary
capture objects | The following Image
types are supported by
syngo.via View&GO: - CT Image
(Computed
Tomography) - MR Image
(Magnetic
Resonance) - NM Image
(Nuclear Medicine) - XA Image (X-Ray
Angiography) - US Image
(Ultrasound) - DX Image (Digital
Radiography) - DICOM secondary
capture objects | Identical | NA |
| Image data
Compression | Receive & Store:
Images are received and
stored as received
without any change in
the compression format.
Display:
Images are displayed as
received without any
change in the
compression.
Lossy compression
images are displayed
with an indication to the
user with the
compression ratio. | Receive & Store:
Images are received and
stored as received
without any change in
the compression format.
Display:
Images are displayed as
received without any
change in the
compression.
Lossy compression
images are displayed
with an indication to the
user with the
compression ratio. | Identical | NA |
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
| | To DICOM Node:
Images are sent as per
the DICOM
negotiation.
Uncompressed is
preferred and lossy
compression is not
supported. | To DICOM Node:
Images are sent as per
the DICOM
negotiation.
Uncompressed is
preferred and lossy
compression is not
supported. | | |
| | To Exchangeable
media: Images exported
as stored in the local
storage. | To Exchangeable
media: Images exported
as stored in the local
storage. | | |
| | Supported
Compressions for
export: lossless
compression
algorithms, JPEG,
JPEG 2000 and RLE. | Supported
Compressions for
export: lossless
compression
algorithms, JPEG,
JPEG 2000 and RLE. | | |
| Operating
system | Workplace:
Microsoft Windows 10
- 64 bit or higher
Microsoft Windows 7 –
64 bit SP1
(for update only) | Workplace:
Microsoft Windows 10 - 64 bit or higher
Microsoft Windows 7 –
64 bit SP1
(for update only) | Identical | NA |
| Impact on Image
Generating
Devices | None.
syngo.via View&GO is
a pure post processing
software and there is no
influence on the image
generating devices | None.
syngo.via View&GO is
a pure post processing
software and there is no
influence on the image
generating devices | NA as both
the devices do
not impact the
Image
generating
devices. | NA |
| CAD
Functionalities | None.
No automated
diagnostic
interpretation
capabilities like CAD
are included. All image
data are to be
interpreted by trained
personnel. | None.
No automated
diagnostic
interpretation
capabilities like CAD
are included. All image
data are to be
interpreted by trained
personnel. | NA as both
the devices
don't support
any CAD
functionalities
. | NA |
| Software self-
test / checks | Alert the user in case
the data transfer is
interrupted to the
connected DICOM
node.
Hardware / Operating
system compatibility
check during
Installation. | Alert the user in case
the data transfer is
interrupted to the
connected DICOM
node.
Hardware / Operating
system compatibility
check during
Installation. | Identical | NA |
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
| | Display Compatibility
Check supports the end
user to qualify the
system for proper
diagnostic use. | Display Compatibility
Check supports the end
user to qualify the
system for proper
diagnostic use. | | |
| Cyber Security | - User access control
- Audit trails
- Documentation of
- system security
information, - Network traffic &
- Firewall control
- Support of virus /
- malware protection. | - User access control
- Audit trails
- Documentation of
- system security
information, - Network traffic &
- Firewall control
- Support of virus /
- malware protection. | Identical | NA |
| Hardware | Hardware is not
understood as part of the
medical device but
needs to comply with
the minimum
requirements as
specified by syngo.via
View&GO. | Hardware is not
understood as part of
the medical device but
needs to comply with
the minimum
requirements as
specified by syngo.via
View&GO. | Identical | NA |
| Software Functionalities | | | | |
| Graphical User
Interface | Yes, with reduced
color palette, clearer
structure and text
labels on icons. | Yes, with reduced color
palette, clearer structure
and text labels on icons | Similar - The
changes are
limited to the
common look
and feel
based on
Siemens
Healthineers
User
Interface
Style Guide. | The changes
between the
predicate device
and the subject
device doesn't
impact the safety
and effectiveness
of the subject
device as the
necessary
measures were
taken for the
safety and
effectiveness of
the subject
device. |
| Patient Browser | Yes, with simplified
search functionality,
clearer structure of
search results, image
preview, unlimited
search results, periodic
updates of search
results. | Yes, with simplified
search functionality,
clearer structure of
search results, image
preview, unlimited
search results, periodic
updates of search
results. | Identical | NA |
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
| Series navigator | The Series Navigator
lists all currently
loaded data within a
workflow. | Yes, the Series
Navigator lists all
currently loaded data
within a workflow. | Identical | NA |
| Findings /
Reporting | No, reporting support
is provided to create
reports using any 3rd
party reporting tool.
Hence the findings
also cannot be
navigated. | No, reporting support is
provided to create
reports using any 3rd
party reporting tool.
Hence the findings also
cannot be navigated. | Identical | NA |
| Import and
export of data | Import of DICOM data
from network nodes or
external media, and of
DICOM-compliant or
non DICOM-
compliant data from
external media and
Windows file system.
Export to USB,
Windows file system,
or other DICOM
nodes. | Import of DICOM data
from network nodes or
external media, and of
DICOM-compliant or
non DICOM-
compliant data from
external media and
Windows file system.
Export to USB,
Windows file system,
or other DICOM
nodes. | Identical | NA |
| Archiving data | Data can be sent to an
archive if syngo.via
View&GO is
connected to a PACS
or corresponding
DICOM node. | Data can be sent to an
archive if syngo.via
View&GO is
connected to a PACS
or corresponding
DICOM node. | Identical | NA |
| Ranges | Yes, parallel, radial,
Radial sliced, Curved
and Spine ranges are
supported.
Additionally,
Anatomical Range
presets 3 can be
created. | Yes, parallel, radial,
Radial sliced, Curved
and Spine ranges are
supported.
Additionally,
Anatomical Range
presets 4 can be
created. | Spine Ranges
and Range
presets are
also
supported for
MR images
in the subject
device. | This difference
between the
predicate device
and the subject
device doesn't
impact the safety
and effectiveness
of the subject
device as the
necessary
measures were
taken for the
safety and |
| | Subject device | Predicate device | Comparison | Impact to
Safety &
Effectiveness |
| | | | | effectiveness of
the subject
device. |
| Spine/Rib
labeling | Yes, with suggested
spine labels to be
confirmed by the user,
and additional smart
placement of labels,
also in inter-vertebra
regions, support of 2D
images, support of
multi-series studies,
and added support for
rib labels. | Yes, with suggested
spine labels to be
confirmed by the user,
and additional smart
placement of labels,
also in inter-vertebra
regions, support of 2D
images, support of
multi-series studies,
and added support for
rib labels. | The Spine /
Rib labeling
functionality
can be
invoked
directly from
Corner Menu
instead of
invoking it
via Range
tool to
facilitate
direct access
for the user.
The
underlying
algorithm has
not changed
beyond bug
fixing. | The changes
between the
predicate device
and the subject
device doesn't
impact the safety
and effectiveness
of the subject
device as the
necessary
measures were
taken for the
safety and
effectiveness of
the subject
device |
| Communication | Yes, Interface with
DICOM is supported. | Yes, Interface with
DICOM is supported. | Identical | NA |
| Printing | Yes, both paper and
DICOM printing
supported. | Yes, both paper and
DICOM printing
supported. | Identical | N/A |
| Online help
system | Yes, with reduced
color palette, clearer
structure and text
labels on icons. | Yes, with reduced
color palette, clearer
structure and text
labels on icons. | Identical | NA |
| Markers and
annotations | Yes, - with support for
marking a position
on an image and
textual
annotations. | Yes, - with support for
marking a position
on an image and
textual
annotations. | Identical | NA |
7
1 Rib Labeling as a functionality was already covered by a 510(k) clearance with device SYNGO, CT BONE READING, K123584.
² Rib Labeling as a functionality was already covered by a 510(k) clearance with device SYNGO, CT BONE READING, K123584.
510(k) Summary for syngo.via View&GO VA30A
8
9
10
11
3 Range Presets as a functionality was already covered by a 510(k) clearance with device syngo.via (version VB40A), K191040
4 Range Presets as a functionality was already covered by a 510(k) clearance with device syngo.via (version VB40A), K191040
510(k) Summary for syngo.via View&GO VA30A
12
Table 1: Substantial equivalency information
13
8. Non-clinical Performance Testing:
Non-clinical tests were conducted for the device syngo.via View&GO during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthcare GmbH claims conformance to the following standards:
- NEMA PS 3.1 3.20 (2016a) Digital Imaging and Communications in Medicine -(DICOM) Set
- ISO/IEC 10918-1 First edition 1994-02-15 + Technical Corrigendum 1 (2005) (JPEG) -
- ISO/IEC 15444-1:2016 (JPEG2000) -
- ISO 14971 Second edition 2007-03-01 -
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION -
- IEC 82304-1 Edition 1.0 2016-10 -
- -IEC 62366-1 Edition 1.0 2015-02
- IEEE Std 3333.2.1-2015 -
Software Verification and Validation:
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 also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.via View&GO during product development.
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 for the device was found acceptable to support the claims of substantial equivalence.
Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device syngo.via View&GO.
Summary:
Performance tests were conducted to test the functionality of the device syngo.via View&GO. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
14
9. Safety and Effectiveness Information:
Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
10. Conclusion as to Substantial Equivalence:
The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.
In summary, we are of the opinion that the subject device syngo.via View&GO, software version VA30A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.