Who is the manufacturer of SYNGO.VIA?

Siemens AG Medical Solutions filed the 510(k) submission for SYNGO.VIA (K123920).

What is the FDA product code for SYNGO.VIA?

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?

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

What are the predicate devices for SYNGO.VIA?

syngo.via (K123375); SOMATOM Definition Edge CT System (K120579); syngo.CT Vascular Analysis (K112020); Software syngo MR D13A for MAGNETOM systems (K121434); syngo TrueD (K101749).

Who can help prepare an FDA 510(k) submission like SYNGO.VIA?

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

K123920 · Siemens AG Medical Solutions · LLZ · Jan 18, 2013 · Radiology

Device Facts

Record ID	K123920
Device Name	SYNGO.VIA
Applicant	Siemens AG Medical Solutions
Product Code	LLZ · Radiology
Decision Date	Jan 18, 2013
Decision	SESE
Submission Type	Traditional
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 is a software-only PACS solution for viewing, manipulating, communicating, and storing medical images. It integrates with RIS via HL7/DICOM to support clinical workflows. Operated by physicians/technicians in clinical environments, it provides tools for image post-processing (MPR, MIP, VRT, registration, quantitative measurements) and anatomy labeling. It functions as a standalone system or with cleared syngo software options. The device assists in diagnosis and treatment planning by enabling fast access to radiological data and structured reporting. It does not control connected modalities. Benefits include improved workflow efficiency and centralized data management.

Clinical Evidence

Bench testing only. Software verification and validation (Unit, Integration, and System levels) performed according to standards including IEC 62304, ISO 14971, and DICOM. No clinical data provided.

Technological Characteristics

Software-only system; runs on standard IT hardware (Windows 2008 Server backend; Windows XP/Vista/7 clients). Supports DICOM/HL7. Features include MPR, MIP, MinIP, VRT, SSD, registration, and quantitative measurements. Connectivity via TCP/IP. Standards: DICOM, ISO/IEC 15444-1, ISO/IEC 10918-1, HL7, IEC 62304, IEC 62366, ISO 14971, IEC 60601-1-4.

Indications for Use

Indicated for use by clinicians in healthcare institutions (Radiology, Nuclear Medicine, Cardiology) for viewing, manipulating, communicating, and storing medical images to support diagnosis and treatment planning. Not indicated for digital mammography diagnosis.

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 (K123375)
SOMATOM Definition Edge CT System (K120579)
syngo.CT Vascular Analysis (K112020)
Software syngo MR D13A for MAGNETOM systems (K121434)
syngo TrueD (K101749)

Related Devices

K123375 — SYNGO.VIA · Siemens AG · Nov 20, 2012
K150843 — syngo®.via (version VB10A) · Siemens AG · Apr 24, 2015
K071114 — SYNGO IMAGING (VERSION V30) · Siemens AG Medical Solutions · May 22, 2007
K101666 — SYNGO. PLAZA VA20A · Siemens AG Medical Solutions · Aug 10, 2010
K182208 — syngo.via View&GO (Version VA10A) · Siemens Healthcare GmbH · Sep 7, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ K123920 # 510(k) Summary This summary of 510(k) safety and effectiveness information is being I his summary of STORIS, with the requirements of SMDA 1990 and 21 CFR §807.92. # I. GENERAL INFORMATION Contact Person: #### Establishment: . Address: . . Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany - Registration Number: 3002808157 . Sabine Schroedel Regulatory Affairs Manager Telephone: +49 (9131) 84-8285 +49 (9131) 84-2792 Fax: # Device Name and Classification: | Trade Name: | syngo.via | |-----------------------|------------------------------------------------| | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.2050 | | Device Class: | Class II | | Product Code: | LLZ | {1}------------------------------------------------ # II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUB-STANTIAL EQUIVALENCE DETERMINATION ## Device Description and Intended Use: This premarket notification covers Siemens' enhanced PACS system svngo.via. 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. The system is a software only medical device. It defines minimum rea no byeten is to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. The predicate device, syngo.via allows for the use of a variety of advanced applications (clinical applications) These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. ## syngo.via Data Management ... ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy. {2}------------------------------------------------ ## Integration: The Workflow Management enables by integration of any HL7- / DICOMcompatible RIS (IHE Year 5) to the syngo product family a consistent workflow - from patient registration to requirement scheduling to a personal work list and supports therefore reporting, documentation or administrative tasks. #### Technological Characteristics: syngo.via is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. This hardware has to fulfil the defined requirements. The backend communication and storage solution is based on Windows 2008 operating system. The client machines are based on Windows XP, Windows Vista and Windows 7. Any hardware platform, which complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The herewith described syngo.via supports DICOM formatted images and objects. The syngo via will be marketed as a software only solution for the enduser (with recommended hardware requirements). Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians. syngo.via will be used for viewing, manipulation, communication, and storage of medical images. The predicate device syngo.via is also capable of viewing, manipulation, communication, and storage of medical images. The difference between the syngo.via and the predicate device syngo.via are to give the subject device greater capabilities than the predicate device, syngo, via has similar technological characteristics as the predicate device and is similar to the functionalities of the predicate device. {3}------------------------------------------------ | Functionality | Principal Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | | transfer protocol for use inside syngo@.via | transfer protocol for use inside syngo@.via | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | | syngo.via | syngo.via VA20A | SOMATOM Definition Edge CT System | syngo.CT Vascular Analysis | Software syngo MR D13A for MAGNETRON systems. | syngo TrueD | Image data compression | Lossless compression with compression factor 2 to 3 and lossy compression with higher compression rate. Receive and decompress of JPEG2000 compressed images. | Lossless compression with compression factor 2 to 3 and lossy compression with higher compression rate. Receive and decompress of JPEG2000 compressed images. | None | | FDA Clearance | K123375 | K120579 | K112020 | K121434 | K101749 | Imaging Algorithms | MPR; MIP; MinIP; VRT; SSD; Digitally Reconstructed Radiograph; Editor functionality / Clip-Box / ClipPlane; Registration; Region Growing; Quantitative measurements such as distance; angle. | MPR; MIP; MinIP; VRT; SSD; Digitally Reconstructed Radiograph; Editor functionality / Clip-Box / ClipPlane; Registration; Region Growing; Quantitative measurements such as distance; angle. | N/A | | | Manufacturer | Siemens AG Medical Solutions | Siemens AG Medical Solutions | Siemens AG Medical Solutions | Siemens AG Medical Solutions | Siemens AG Medical Solutions | Siemens AG Medical Solutions | Hardware/OS | Client: PC with Windows XP, Windows Vista, Windows 7 | Client: PC with Windows XP, Windows Vista, Windows 7 | PC with Windows XP Professional, Celsius Hardware | | 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 | 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 | The Siemens SOMATOM Definition Edge (Project P46F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.(*spiral planes: the axial | syngo.CT Vascular Analysis is an image analysis software package for evaluating enhancedCT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP | The MAGNETOM systems described above are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or | syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. | | | | Not Applicable - not a stand-alone medical device. | | interpretation and evaluation of exami- nations within healthcare institu- tions, for example, in Radiology, Nu- clear Medicine and Cardiology envi- ronments. The system is not approved in the U.S. for the display- ing of digital mamm ography images for diagnosis. | interpretation and evaluation of exami- nations within healthcare institu- tions, for example, in Radiology, Nu- clear Medicine and Cardiology envi- ronments. The system is not approved in the U.S. for the display- ing of digital mamm ography images for diagnosis. | planes resulted from the continuous rota- tion of detectors and x-ray tube, and the simultaneous transla- tion of the patient.) | thin/thick, volume rendering technique (VRT), curved pla- nar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table re- moval) and evalua- tion tools (vessel centerline calculation, lumen calculation, stenosis calculation) and re- porting tools (lesion location, lesion char- acteristics and key images), the soft- ware package is de- signed to support the physi- cian in confirming the presence or ab- sence of physician- identified lesions in blood vessels and evaluation, docu- mentation and fol- low-up of any such | extremities. Other physical pa- rameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These im- ages and/or spectra and the physical pa- rameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices | The images can be viewed in a number of output formats including MIP and volume rendering. syngo TrueD enables visualization of in- formation that would otherwise have to be visually compared disjointedly. syngo TrueD provides ana- lytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and ther- apy follow-up ex- aminations. syngo TrueD is designed to support the on- cological workflow by helping the user to confirm the ab- sence or presence of lesions, including evaluation, quantifi- cation, follow-up and documentation | | | | Minimum Requirements - Intel Pentium IV Processor, 2.00 GHz, MS Win- | | | Image communication | Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image | Standard network protocols like TCP/IP and standard communication protocol DICOM. | Standard network protocols like TCP/IP and standard communication protocol DICOM. | | | | PC with Windows XP Professional, Celsius Hardware | | | | | | lesion. These visualization/processing/evaluation tools allow for characterization of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue. | Not Applicable – not a stand-alone medical device. | such as in-room display and MR-safe biopsy needles | of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems. syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning. | Standard network protocols like TCP/IP and standard communication protocol DICOM. | | None | None | None | | | | N/A | N/A | N/A | | | | | | | | Predicate Device Comparison Table مز . Page K7 November 30, 2012 510(k) for syngo®.via enhanced {4}------------------------------------------------ . . Page K8 。『 November 30, 2012 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : · {5}------------------------------------------------ i Page K9 {6}------------------------------------------------ Page K10 November 30, 2012 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {7}------------------------------------------------ | | Server Windows Server 2008 R2 (HW is not understood as part of the medical device, but needs to comply to the minimum requirements as specified by syngo.via) | Server Windows Server 2008 R2 (HW is not understood as part of the medical device, but needs to comply to the minimum requirements as specified by syngo.via) | Software package attached to Modality Scanner (CT) | dows XP SP1 or later Software package attached to Modality Scanner (MR) | | | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----| | Major Safety Characteristics | subject device is a post- processing software package with no implemented capability to control the connected modalities; support of quality assurance methods such as SMPTE; HIPAA; major software self tests / checks. | subject device is a post- processing software package with no implemented capability to control the connected modalities; support of quality assurance methods such as SMPTE; HIPAA; major software self tests / checks. | subject device is a post- processing software package with no implemented capability to control the connected modalities; support of quality assurance methods such as SMPTE; HIPAA; major software self tests / checks. | subject device is a post- processing software package with no implemented capability to control the connected modalities; support of quality assurance methods such as SMPTE; HIPAA; major software self tests / checks. | | | | Automatic Spine Labeling | Anatomy Labeling | Not applicable | Anatomy labels are automatically suggested, with manual override possible. | Anatomy labels are automatically suggested, with manual override possible. | N/A | | | Anatomy Labelled | Vertebra bodies | Not applicable | Vertebra bodies and discs | Coronary vessels. | Vertebra bodies and discs | N/A | | Labeling Workflow | Automatically suggested labels are | Not applicable | Automatically suggested labels are | Automatically suggested labels are | Automatically suggested labels are | N/A | Page K11 November 30, 2012 510(k) for syngo®.via enhanced {8}------------------------------------------------ | | N/A | N/A | |-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | isplayed by unching the wor ow function. iditing of labels is orovided to oversis he automatically he automatically uggested labels. | st verification step provided where there there there the according the accounting accounts the accountry habest ing. | Supports manual editing of labelling of labelling of the bels. | | diting of labels is is overrist rovided to overrist te automatically Iggested labels. splayed by unching the wor ow function. | N/A | upports manual diting of labels. Acluding instelling instelling including including delection of delection of delection of delection of delection of delection of delection de | | splayed by lunching the wor low function. diting of labels i rovided to oversions in the supportunities and | | upports manual diting of lautoma liting of lautoma sertion and del | | | applicabl Not | Not applicable | | diting of labels is is rovided to overrise ne automatics ally uggested labels. isplayed by lunching the wor ow function. | ាន | upports manual nd semi-automal ditimg of lautomas, and semi-aman arough instruments, and sensions, arough instrugues nd delletinon nd deletinon of t | | | abeling Confirm tion | beling Edit | . . Page K12 November 30, 2012 510(k) for syngo®.via enhanced {9}------------------------------------------------ | | Menu of spine labels names provided. | Menu of spine labels names provided. | Menu of vessel labels names provided. | Menu of spine labels names provided. | | | |--|--------------------------------------|--------------------------------------|---------------------------------------|--------------------------------------|------------------------------|-----------------------------------------------------------| | | Cross-sectional imaging (CT, MR) | Not applicable | Cross-sectional imaging (CT) | Cross-sectional imaging (CT) | Cross-sectional imaging (MR) | N/A | | | | | | | | | | | Landmark-based alignment | Not applicable | N/A | N/A | N/A | Landmark-based alignment | | | Across multiple time-points | Not applicable | N/A | N/A | N/A | Across multiple time-points | | | Cross-sectional imaging (CT, MR) | Not applicable | N/A | N/A | N/A | Cross-sectional imaging (CT) | | | Registration verification by user | Not applicable | N/A | N/A | N/A | Registration verification by user | | | Manual registration adjustments made | Not applicable | N/A | N/A | N/A | Manual registration adjustments made through visual tools | : 510(k) for syngo®.via enhanced Page K13 November 30, 2022 {10}------------------------------------------------ Page K14 November 30, 2012 through visual tools : 510(k) for syngo®.via enhanced for synapse.org via SIA enhancement --- {11}------------------------------------------------ ## Summary of Non-Clinical Tests: ## Summary of Non-Clinical Tests: The software verification and validation (Unit Test Level, Integration Test Level and System Test Level) was performed for all newly developend components and the complete system according to the following standards: - DICOM Standard [2011] - ISO/IEC 15444-1:2005+TC 1:2007 - ISO/IEC 10918-1:1994 + TC 1:2005 - HL7 [2006] - IEC 62304:2006 - IEC 62366:2007 - ISO 14971:2007 - IEC 60601-1-4:2000 #### General Safety and Effectiveness Concerns: . The device labeling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize hazards, Siemens adheres to recognized and established industry practice and standards. syngo.via conforms to the applicable FDA recognized and international IEC, ISO, and NEMA standards with regards to performance and safety as recommended by the respective FDA Guidance Document. {12}------------------------------------------------ #### Substantial Equivalence: . The syngo.via extended functionalities addressed in this premarket notification, is substantially equivalent to the following commercially available devices: | Manu- facturer | Predicate Device Name | FDA Clearance Number | |-------------------|------------------------------------------------------------------------|-------------------------| | Siemens | syngo.via | K123375 | | Siemens | SOMATOM Definition Edge CT System | K120579 | | Siemens | syngo.CT Vascular Analysis | K112020 | | Siemens | Software syngo MR D13A for MAGNETOM systems Aera/Skyra/Avanto/Verio | K121434 | | Siemens | syngo TrueD | K101749 | The added capabilities to syngo.via described in this 510(k) has similar functionalities that can be found in the devices listed above In summary, Siemens is of the opinion that syngo.via does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate devices. {13}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 January 18, 2013 Siemens AG Healthcare SY % Mr. Norbert Stuiber Responsible Third Party Official TUV America Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112 Re: K123920 Trade/Device Name: syngo®:via Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 14, 2012 Received: December 20, 2012 Dear. Mr. Stuiber: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, alore, many interest of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {14}------------------------------------------------ Page 2-Mr. Stuiber forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire spoonis advice tory DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Racioney by reference to premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, # Sean M. Boyd -S for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {15}------------------------------------------------ # INDICATIONS FOR USE | 510(k) Number (if known): | ____________________________________________________________________________________________________________________________________________________ | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | syngo ®. via | #### Indications For Use: syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. and storage of medical mages. 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 syngo. Na supports intorprotation and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the ા કર X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 801 Subpart C) (Please do not write below this line - continue on another page if needed) AND / OR _____________________________________________________________________________________________________________________________________________________________________________ Concurrence of the CDRH, Office of In Vitro Diagnostic Devices (OIVD) si. 7 Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K123920 Page 1 of *_*_