(209 days)
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No
The document describes a medical image viewing and processing workstation without mentioning any AI or ML capabilities.
No
The device is described as a workplace for viewing, manipulating, communicating, and storing medical images for diagnostic purposes, not for direct treatment or therapy.
Yes
The device is described as aiding "doctors in the evaluation of digital radiological examinations" and is used for "viewing, manipulation, communication, and storage of medical images," which directly supports diagnostic activities even if it explicitly states it doesn't support mammography for diagnosis.
Yes
The device description explicitly states it is a "syngo-based workplace" and "syngo is a universal imaging platform based on Windows XP," indicating it is primarily a software platform for viewing and processing medical images. While it interacts with modalities and potentially hardware for display, the core device being described and cleared is the software itself.
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 data exchange media." This describes a system for handling and displaying medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on a "syngo-based workplace that supports different modalities" and helps doctors "view, optimize process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information." This reinforces its role in image management and review.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
The device is clearly intended for the handling and display of medical images acquired from various imaging modalities, which falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an IVD.
N/A
Intended Use / Indications for Use
The syngo MultiModality Workplace is intended to be used for viewing, manipulation, communication, and storage of medical images and data exchange media.
The syngo MultiModality Workplace can be used as a stand-alone device or as with a variety of cleared and unmodified syngo- and Windows XP-based software options.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
This premarket notification covers only the Siemens syngo MultiModality Workplace (sMMWP) (VE26A), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syngo MultiModality Workplace (sMMWP) (VE26A) offers a comprehensive solution to view, optimize process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.
Due to special customer requirements based in the modality image type and the clinical focus, the syngo MultiModality Workplace (sMMWP) (VE26A) can be offered with different combinations of cleared and unmodified clinical applications. syngo applications can be added to the MultiModality Workplace either individually or as clinically focused packages.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
DICOM formatted images and information
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
doctors
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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APR 2 2 2008 く
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.
I. General Information
Establishment
Address
Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany
3002808157
Registration Number
Contact Person
Ms. Sabine Schroedel Regulatory Affairs Manager Phone: +49-(9131) 84-8285 Fax: +49 (9131) 84-2792
Device Name
Trade Name Classification Classification Panel CFR Section Device Class Product Code
syngo MultiModality Workplace (sMMWP) (VE26A) Picture Archiving and Communications System (PACS) Radiology 21 CFR §892.2050 Class II LLZ
Date of Preparation of Summary: March 17, 2008
510(k) for sMMWP
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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Intended Use
The syngo MultiModality Workplace is intended to be used for viewing, manipulation, communication, and storage of medical images and data exchange media.
The syngo MultiModality Workplace can be used as a stand-alone device or as with a variety of cleared and unmodified syngo- and Windows XP-based software options.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
Device Description
This premarket notification covers only the Siemens syngo MultiModality Workplace (sMMWP) (VE26A), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syngo MultiModality Workplace (sMMWP) (VE26A) offers a comprehensive solution to view, optimize process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.
Due to special customer requirements based in the modality image type and the clinical focus, the syngo MultiModality Workplace (sMMWP) (VE26A) can be offered with different combinations of cleared and unmodified clinical applications. syngo applications can be added to the MultiModality Workplace either individually or as clinically focused packages.
Technological Characteristics
The syngo MultiModality Workplace (sMMWP) (VE26A) will be marketed as a software only solution for the end user (with recommended hardware requirements) or as a complete workstation for the end user (hardware and software package). It will be installed by Siemens service engineers. The syngo MultiModality Workplace (sMMWP) (VE26A) described supports DICOM formatted images and information. The workplace is based on the Windows XP operating system.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings, 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 electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
510(k) for sMMWP
July 23, 2007
2
Substantial Equivalence
The syngo MultiModality Workplace (sMMWP) (VE26A), addressed in this premarket notification, is substantially equivalent to the following commercially available device:
| Predicate Device Name | FDA Clearance
Number | Manufacturer |
|-------------------------------|-------------------------|--------------|
| syngo MultiModality Workplace | K061964 | Siemens |
The syngo MultiModality Workplace (sMMWP) (VE26A) described in this premarket notification has the same intended use and similar technical characteristics as the device listed above.
In summary, Siemens is of the opinion that the syngo MultiModality Workplace (sMMWP) (VE26A) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2008
Siemens AG, Medical Solutions % Mr. Stefan Preiss TUV SUD America, Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891
Re: K072728
Trade/Device Name: syngo MultiModality Workplace (sMMWP) (VE26A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 4, 2008 Received: April 9, 2008
Dear Mr. Preiss:
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. Insting 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 such 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) _ Device Name: ___ syngo MultiModality Workplace (sMMWP) (VE26A)
Indications for Use:
The syngo MultiModality Workplace is intended to be used for viewing, manipulation, communication, and storage of medical images and data exchange media.
The syngo MultiModality Workplace can be used as a stand-alone device or as with a variety of cleared and unmodified syngo- and Windows XP-based software options.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _ (Part 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
r============================================================================================================================================================================ Concurrence of the CDRH of Device Evaluation (ODE)
510(k) for sMMWP
July 23, 2007
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(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072728
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