Who is the manufacturer of syngo.via (Version VB40A)?

Siemens Healthcare GmbH filed the 510(k) submission for syngo.via (Version VB40A) (K191040).

What is the FDA product code for syngo.via (Version VB40A)?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for syngo.via (Version VB40A)?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for syngo.via (Version VB40A)?

syngo.via (Version VB10A) (K150843).

Who can help prepare an FDA 510(k) submission like syngo.via (Version VB40A)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

syngo.via (Version VB40A)

K191040 · Siemens Healthcare GmbH · LLZ · May 16, 2019 · Radiology

Device Facts

Record ID	K191040
Device Name	syngo.via (Version VB40A)
Applicant	Siemens Healthcare GmbH
Product Code	LLZ · Radiology
Decision Date	May 16, 2019
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

Intended Use

syngo.via 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 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.

Device Story

syngo.via (VB40A) is a client-server software for viewing, manipulating, and storing medical images (CT, MR, NM, XA, US, DX). Server processes/renders data from modalities; client provides UI for interactive viewing. Used by clinicians in radiology, nuclear medicine, and cardiology. Features include multiplanar reconstruction (MPR), intensity projections (MIP/MinIP), volume rendering (VRT/cVRT), organ segmentation (heart, lung, aorta), and change visualization. Supports DICOM/HL7 interoperability. Enhances clinical workflow by providing tools for image interpretation and reporting. Benefits include improved visualization of anatomical structures and changes over time, facilitating diagnostic evaluation.

Clinical Evidence

Bench testing only. No clinical data. Verification and validation testing confirmed software specifications met acceptance criteria. Conformance to standards including NEMA PS 3.1-3.20, ISO 10918-1, ISO 15444-1, IEC 62304, IEC 82304-1, IEC 62366-1, and ISO/HL7 21731.

Technological Characteristics

Client-server software architecture; runs on standard IT hardware (Windows OS). Supports DICOM/HL7. Imaging algorithms: MPR, MIP/MinIP, VRT, cVRT, SSD, organ segmentation, change visualization, spine/rib labeling. Cybersecurity: user access control, audit trails, system hardening, device guard. Software class: Moderate Level of Concern per FDA guidance.

Indications for Use

Indicated for viewing, manipulation, communication, and storage of medical images in healthcare institutions (Radiology, Nuclear Medicine, Cardiology). Not for digital mammography diagnosis in the U.S.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

syngo.via (Version VB10A) (K150843)

Reference Devices

syngo.CT LungCAD (K143196)
syngo.CT Bone Reading (K123584)

Related Devices

K150843 — syngo®.via (version VB10A) · Siemens AG · Apr 24, 2015
K201477 — syngo.via View&GO · Siemens Healthcare GmbH · Jul 1, 2020
K182208 — syngo.via View&GO (Version VA10A) · Siemens Healthcare GmbH · Sep 7, 2018
K221501 — syngo.via View&GO · Siemens Healthcare GmbH · Oct 14, 2022
K123920 — SYNGO.VIA · Siemens AG Medical Solutions · Jan 18, 2013

Submission Summary (Full Text)

{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. May 16, 2019 Siemens Healthcare GmbH % Mr. Georg Bauer Responsible Third-Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112 Re: K191040 Trade/Device Name: syngo.via (Version VB40A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 17, 2019 Received: April 19, 2019 Dear Mr. Bauer: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191040 Device Name syngo.via (Version VB40A) syngo.via is a software solution intended to be used for viewing, manipulation, 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 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. | | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> 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." Type of Use (Select one or both, as applicable) {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: April 03, 2019 - 1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Mr. Elango Alampalayam Rangappan Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: ar.elango@siemens-healthineers.com Telephone: +49 (9191) 18-4429 Fax: +49 (9191) 18-4404 #### 3. Device Name and Classification: | Trade Name: | syngo.via (Version VB40A) | |-----------------------|---------------------------------------------| | Classification Name: | Picture Archiving and Communications System | | 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 (Version VB10A) | |-----------------------|-------------------------------------------------------------------------------| | 510(k) Clearance: | K150843 | | Clearance Date: | April 25, 2015 | | 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 Picture Archiving and Communications System, syngo.via. software version VB40A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via, software version VB10A. syngo.via 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 and therefore not in the scope of this 510(k) submission. syngo.via provides tools and features to cover the radiological tasks reading images and reporting. syngo.via supports DICOM formatted images and objects. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite, syngo.via interoperates with a Radiology Information System (RIS) to enable customer specific workflows. syngo.via is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage, and incorporates the local database. The client provides the user interface for interactive image viewing and can be installed and started on each workplace that has a network connection to the server. The server's backend communication and storage solution is based on Microsoft Windows server operating systems. The client machines are based on Microsoft Windows operating systems. syngo.via 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, software version VB40A, as well as the predicate device, syngo.via, software version VB10A. # 6. Intended Use: syngo.via 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 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. {5}------------------------------------------------ # 7. Summary of Differences between the Subject Device and the Predicate Device: The differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table: | | Subject device | Predicate device | Comparison | Impact to Safety & Effec- tiveness | |------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name and version (K number) | syngo.via (Version VB40A) | syngo.via (Version VB10A) (K150843) | New product version | NA | | Manufacturer | Siemens Healthcare GmbH | Siemens AG Medical Solutions | Legal manufacturer change22. | NA | | Intended use | syngo.via is a software solution in- tended to be used for viewing, manipu- lation, 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 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 dis- playing of digital mammography im- ages for diagnosis in the U.S. | syngo.via is a software solution in- tended to be used for viewing, manipu- lation, 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 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 dis- playing of digital mammography im- ages for diagnosis in the U.S. | Same | NA | | | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness | | Software architecture | Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules. | Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules. | Same | NA | | Image communication | Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image transfer protocol for use inside syngo.via between the client and server. | Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image transfer protocol for use inside syngo.via between the client and server. | Same | NA | | Imaging algorithms | Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT) with additional technique Cinematic VRT for photorealistic rendering Shaded Surface Display (SSD) Editor functionality (e.g. ClipBox) Registration Anatomical registration Region growing with single click region growing Organ segmentation based on existing ALPHA technology. Change Visualization Automatic Spine Labeling, also for ribs in CT thorax scans13 (“Rib labeling”) | Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT) Shaded Surface Display (SSD) Editor functionality (e.g. ClipBox) Registration Anatomical registration Region growing Automatic Spine Labeling, also for ribs in CT thorax scans23 (“Rib labeling”) | There are enhancements to the existing algorithms in the subject device compared to the predicate device. cVRT: Cinematic VRT is an extension to the standard VRT rendering algorithm to visualize the photorealistic images. Organ Segmentation: Organ Segmentation is an enhancement based on the existing but improved ALPHA technology to visualize the anatomical regions Heart, Lung and Aorta. Change Visualization: This algorithm helps to visualize the anatomical changes | 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 taken for the safety and effectiveness of the subject device. | | | Subject device | Predicate device | Comparison | Impact to Safety & Effec- tiveness | | | | | in the lung region between two series belonging to different time points. | | | Quantitative algo- rithms | Distance and angle measurements | Distance and angle measurements | Same | NA | | Supported Image Generating Modali- ties | The following Image types are sup- ported by syngo.via: - CT Image (Computed Tomogra- phy) - 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 sup- ported by syngo.via: - CT Image (Computed Tomogra- phy) - MR Image (Magnetic Resonance) - NM Image (Nuclear Medicine) - XA Image (X-Ray Angiography) - US Image (Ultrasound) - DX Image (Digital Radiography) - DICOM secondary capture objects | Same | NA | | Image data Com- pression | Receive & Store: Images are received and stored as re- ceived without any change in the com- pression format. Display: The images are displayed as received without any change in the compres- sion. Lossy compression images are dis- played with an indication to the user with the compression ratio. Export: To DICOM node and Exchangeable media: Images are sent as per the DI- | Receive & Store: Images are received and stored as re- ceived without any change in the com- pression format. Display: The images are displayed as received without any change in the compres- sion. Lossy compression images are dis- played with an indication to the user with the compression ratio. Export: To DICOM node and Exchangeable media: Images are sent as per the DI- | Same | NA | | | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness | | | COM negotiation and depending on Compression settings. Lossy compres- sion is not supported. | COM negotiation and depending on Compression settings. Lossy compres- sion is not supported. | | | | | 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 | Client: Microsoft Windows 7 SP1 or Mi- crosoft Windows 8.1 or Microsoft Windows 10 Server: Microsoft Windows Server 2008 R2 or Microsoft Windows Server 2012 R2. or Microsoft Server 2016 | Client: Microsoft Windows 7 SP1 or Mi- crosoft Windows 8.1 Server: Microsoft Windows Server 2008 R2 or Microsoft Windows Server 2012 R2 | In the subject device client supports the Microsoft Windows 10 Operating system and Server supports Microsoft Windows Server 2016 additionally com- pared to the predicate de- vice. | This Operating System dif- ference between the predi- cate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device. | | Impact on Image Generating Devices | None syngo.via is a pure post processing software and no influence on the im- age generating devices. | None syngo.via is a pure post processing software and no influence on the im- age generating devices. | NA as both the devices do not impact the Image gen- erating devices. | NA | | CAD Functionali- ties | None. No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. Note: The LungCAD Navigation Tool provides the user interface to visualize the results of the external LungCAD algorithm which is cleared with syn- go.CT LungCAD as an accessory (K143196). | 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. Note for Subject device: The LungCAD Navigation tool doesn't provide any CAD Functionality rather only provides the user in- terface to view the results generated by external LungCAD algorithm. | NA | | | Subject device | Predicate device | Comparison | Impact to Safety & Effec- tiveness | | Software self-test / checks | Indicates the user in case that data coming from an interface cannot be assigned to a task flow to assign it manually. In case of a data mismatch due to in- correct or inconsistent use of DICOM rules the administrator can change the data transfer protocol and patient identification rules (DICOM Parser Tool). When the audit trail folder exceeds the configured level of storage, a warning message is sent to the administrator by e-mail, if configured. Client installation is prevented auto- matically in case if the system doesn't have the recommended operating sys- tem. Also during the launch of the client every time, the compatibility to the server version…