Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image rendering and post-processing tools, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.

Therapeutic

No.
The device is indicated for image rendering and post-processing to support interpretation, not for direct treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that 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." Interpretation of medical images for diagnosis falls under diagnostic functions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "syngo.via View&GO is a software-only medical device" and clarifies that the hardware it runs on is not considered part of the medical device and is outside the scope of the 510(k).

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

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 Description: The description clearly states that syngo.via View&GO is a software-only medical device for image rendering and post-processing of DICOM images. It works with images acquired from various imaging modalities (CT, MR, NM, XA, US, DX) and DICOM secondary capture objects.
Intended Use: The intended use is to "support the interpretation in the field of radiology, nuclear medicine and cardiology." This involves analyzing medical images, not analyzing biological specimens.

The device's function is centered around processing and displaying medical images, which is distinct from the analysis of biological samples that defines an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

LLZ

Device Description

Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA40A. This 510(k) submission describes several modifications to the previously cleared predicate device. syngo.via View&GO, software version VA30A.

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 VA40A, as well as the predicate device, syngo.via View&GO, software version VA30A.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

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

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K221501

Reference Device(s)

K213665

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Healthcare GmBH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K230196

February 13, 2023

Trade/Device Name: syngo.via View&GO VA40A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 24, 2023 Received: January 25, 2023

Dear Prithul Bom:

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

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) K230196

Device Name syngo.via View&GO VA40A

Indications for Use (Describe)

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.

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Section E: 510(k) Summary

4

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: January 10, 2023

1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
  Establishment Registration Number: 3004977335

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 VA40A)
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 VA30A)
510(k) Clearance:	K221501
Clearance Date:	October 14, 2022
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
Recall Information:	This predicate device has not been the subject of any
design related recalls.

5

1. Additional Legally Marketed Reference Device

Trade Name:	Syngo Carbon Space VA20A
510(k) Clearance:	K213665
Clearance Date:	June 21, 2022
Classification Name:	Medical Image Management and Processing System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ
Recall Information:	This device has not been the subject of any
design related recalls.

Device Description:

Siemens Healthcare GmbH intends to market the Medical Image Management and Processing System, syngo.via View&GO, software version VA40A. This 510(k) submission describes several modifications to the previously cleared predicate device. syngo.via View&GO, software version VA30A.

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 VA40A, as well as the predicate device, syngo.via View&GO, software version VA30A.

6

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.

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.

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.

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.

7

7. Summary of Differences between the Subject Device and the Predicate Device:

The following table compares the functionality of syngo.via View&GO VA40A to the predicate device syngo.via View&GO VA30A:

| | Subject device | Predicate device | Comparison | Impact to Safety
& Effectiveness |
|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name and
version (K
number) | syngo .via View&GO
(Version VA40A) | syngo .via View&GO
Version VA30A
(K221501) | 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
modules. | Standalone workplace
system that is logically
broken down to syngo.via
View&GO subsystems.
Subsystems are further
broken down to syngo
modules. | Identical | NA |
| 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) | -
Multiplanar
reconstruction (MPR) | Similar:
Algorithms | The changes
between the |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness |
| | 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)
Auto-Contour
Registration
Anatomical
registration
Region growing
Automatic Spine
Labeling, also for ribs
in CT thorax scans
("Rib labeling")
Reprocessing X-ray
projection images
into 3D image and
Topograms
FASTAlign
Cinematic VRT1 | 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)
Auto-Contour
Registration
Anatomical
registration
Region growing
Automatic Spine
Labeling, also for ribs
in CT thorax scans
("Rib labeling")
Reprocessing X-ray
projection images
into 3D image and
Topograms
FASTAlign | underwent bug-
fixing and
minor
improvements.
No re-training
or change in
algorithm
models was
performed.
The cinematic
VRT algorithm
was added, that
was previously
cleared with
K213665. | 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 & angle-
on-stack, VOI and ROI
measurements | Identical | NA |
| 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) | 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) | Identical | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness |
| | DICOM secondary capture objects | DICOM secondary capture objects | | |
| 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.
Export:
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.
Supported Compressions for export: lossless compression algorithms, JPEG, JPEG 2000 and RLE. | 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.
Export:
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.
Supported Compressions for export: lossless compression algorithms, JPEG, JPEG 2000 and RLE. | Identical | NA |
| Operating system | Workplace:
Microsoft Windows 11-64 bit or higher
Microsoft Windows 10 - 64 bit or higher | Workplace:
Microsoft Windows 10 - 64 bit or higher
Microsoft Windows 7 - 64 bit SP1
(for update only) | Windows 11 support included.
Windows 7 support was removed | The changes between the predicate device and the subject device don'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 |
| | Subject device | Predicate device | Comparison | Impact to Safety
& Effectiveness |
| 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.

Display Compatibility
Check supports the end
user to qualify the system
for proper diagnostic use. | Alert the user in case the
data transfer is
interrupted to the
connected DICOM node.

Hardware / Operating
system compatibility
check during Installation.

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 | | | | |
| | Subject device | Predicate device | Comparison | Impact to Safety
& Effectiveness |
| 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 | Identical | NA |
| 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 |
| Series navigator | The Series Navigator
lists all currently loaded
data within a workflow.
Studies are marked with
colorized timepoints. | Yes, the Series Navigator
lists all currently loaded
data within a workflow.
Studies are marked as
"prior" and "current"
according to their
acquisition date. | To improve the
visualization
of studies
according to
their different
timepoints of
acquisition, the
timepoints are
shown in dates
of different
colors and the
study date is
featured more
prominently
with larger and
bold font in the
subject device. | The changes
between the
predicate device
and the subject
device don'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. The
functionality was
previously cleared
with additional
reference device
K213665. |
| 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 | Data can be sent to an
archive if syngo.via | Identical | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety
& Effectiveness |
| | View&GO is connected
to a PACS or
corresponding DICOM
node. | View&GO is connected
to a PACS or
corresponding DICOM
node. | | |
| Ranges | Yes, parallel, radial,
Radial sliced, Curved
and Spine ranges are
supported. Additionally,
Anatomical Range
presets can be created. | Yes, parallel, radial,
Radial sliced, Curved
and Spine ranges are
supported. Additionally,
Anatomical Range
presets can be created. | identical | NA |
| 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. | Identical. | NA |
| 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. | Similar:
AutoContour
and Polygonal
ROI are
accessed by
the user in a
different
manner in the
subject device.
No functional
changes/impro
vements were
implemented
with respect to
the predicate
device. | The changes
between the
predicate device
and the subject
device don'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. |
| Hiding and
Showing of Image
Overlays | - show or hide image
text
show or hide custom
image text | - show or hide image
text
show or hide custom
image text | Shutter-Tool
was added to | The changes
between the
predicate device |
| Subject device | Predicate device | Comparison | Impact to Safety
& Effectiveness | |
| - show or hide
graphical objects
such as annotations
and markers
show or hide
reference lines
show or hide
shutters | - show or hide
graphical objects
such as annotations
and markers
show or hide
reference lines | the subject
device. | and the subject
device don'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. The
functionality was
previously cleared
with additional
reference device
K213665. | |

8

¹ cinematic VRT as a functionality was already covered by a 510(k) clearance with the device syngo.Carbon Space, K213665

9

10

11

12

13

Figure 1: Predicate Device Comparison Table

14

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 14971:2019 Third Edition 2019-12 -
-EC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
IEC 82304-1 Edition 1.0 2016-10 -
-IEC 62366-1 Edition 1.1 2020-06 Consolidated Version
IEEE Std 3333.2.1-2015 -

9. 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 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.

10. Summarv:

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.

9. Safety and Effectiveness Information:

Software specifications, 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.

15

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 V A40A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.

16