(19 days)
K0925519
Not Found
No
The document explicitly states that the device "allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices" and does not mention AI, ML, or related terms.
No
The device is a software solution for viewing, manipulating, communicating, and storing medical images, intended to assist in diagnosis and treatment planning, but it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that syngo via "supports interpretation and evaluation of examinations within healthcare institutions," and the "Device Description" section states it "supports the physician in diagnosis and treatment planning."
Yes
The device description explicitly states, "The system is a software only medical device." It also clarifies that the hardware it runs on is not considered a medical device and is outside the scope of the 510(k) submission.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing, manipulation, communication, and storage of medical images" and supporting "interpretation and evaluation of examinations within healthcare institutions." This focuses on image management and interpretation, not on analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The description reinforces the focus on software for image handling and supporting physician diagnosis and treatment planning based on these images. It explicitly states it's a "software only medical device."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information derived from such tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is centered around medical imaging data, not biological samples.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
Device Description
This premarket notification covers Siemens' enhanced PACS system syngo.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 standalone 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 requirements 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.
syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x (K0925519, cleared on August 27, 2009). 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 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 end-user (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.x is also capable of viewing, manipulation, communication, and storage of medical images.
The difference between the syngo.via and the predicate device syngo.x 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
syngo via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0925519
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510(k) Summary
K123375
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
GENERAL INFORMATION I.
Establishment:
-
Address:
Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany -
. Registration Number: 3002808157
Contact Person:
Sabine Schroedel Regulatory Affairs Manager Telephone: +49 (9131) 84-8285 Fax: +49 (9131) 84-2792
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 syngo.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 standalone 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 requirements 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.
syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x (K0925519, cleared on August 27, 2009). 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.
Integration:
The Workflow Management enables by integration of any HL7- / DICOMcompatible RIS (IHE Year 5) to the syngo product family a consistent workflow -
2
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 end-user (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.x is also capable of viewing, manipulation, communication, and storage of medical images.
The difference between the syngo.via and the predicate device syngo.x 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, see table below:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2012
Siemens AG Healthcare SY % Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K123375
Trade/Device Name: syngo®.via Regulation Number: 21 CFR 2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 30, 2012 Received: November 1, 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
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Page 2 - [Contact Person's Name]
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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/ReportalProblem/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 Division 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris -S
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K123375
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.
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 ഗ.ട.
AND / OR
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)
Concurrence of the CDRH, Office of In Vitto Diagnostic Devices (OIVD)
Димис Димив
D
Division Sign-Off Office of In Vitro Diaggostic Device Evaluation and Safety
510(k) K123325
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510(k) for syngo®.via