(15 days)
No
The document describes a medical diagnostic workstation for viewing and processing images, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on standard image processing and post-processing software options.
No
The device is described as a medical diagnostic workstation intended to assist physicians in diagnosis, surgical planning, interventional procedures, or treatment planning by viewing, manipulating, and storing medical images. It does not actively treat or mitigate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The syngo MultiModality Workplace is a medical diagnostic workstation" and is "intended to assist the physician in diagnosis."
Unknown
The document states the device "will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package)." This indicates it can be sold as software only, but also as a complete hardware and software package, making it unclear if the submission covers only the software component or the combined system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The syngo MultiModality Workplace is described as a medical diagnostic workstation for viewing, manipulating, communicating, and storing medical images and data. It processes digital radiological examinations.
- Lack of mention of biological samples: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues. Its focus is on processing and displaying medical images.
Therefore, the syngo MultiModality Workplace falls under the category of medical imaging software/workstations, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The syngo MultiModality Workplace is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syngo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XP-based software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
Product codes
LLZ
Device Description
This premarket notification covers Siemens syngo MultiModality Workplace (syngo MM WP), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syrgo MultiModality Workplace 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 on the modality image type and the clinical focus, the syngo MultiModality Workplace can be configured with different combinations of clinical applications. syngo applications can be added to the multimodality workplace either individually or as clinically focused packages.
The syneo MultiModality Workplace is a medical diagnostic workplace for realtime viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syneo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XPbased software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software. The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
The syngo MultiModality Workplace will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The syngo MultiModality Workplace described supports DICOM formatted images and information. The workplace is based on the Windows XP operating system.
Mentions image processing
Yes
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
Physician
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)
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
Siemens Medical Solutions, Inc 510(k) for syngo MultiModality Workplace_
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
JUL 27 2006
Establishment: . Address:
| Siemens AG |
|---|
| Medical Solutions |
| Henkestrasse 127 |
| D-91052 Erlangen |
| Germany |
- 3002808157 Registration Number: .
- Ms. Sieglinde West Regulatory Affairs Manager Phone: +49 (9131) 84-3144 Fax: +49 (9131) 84-2792
Device Name:
.
- syngo MultiModality Workplace (syngo MM WP) Trade Name: . Picture Archiving and Communications System (PACS)
- . Classification:
- Classification Panel: .
Contact Person:
- 21 CFR §892.2050 CFR Section: .
- . Device Class: Class Hass H 1902
Radiology
. Product Code:
Date of Preparation of Summary: June 24th, 2006
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
. Device Description and Intended Use:
This premarket notification covers Siemens syngo MultiModality Workplace (syngo MM WP), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syrgo MultiModality Workplace offers a comprehensive solution to view, optimize, process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.
1
Due to special customer requirements based on the modality image type and the clinical focus, the syngo MultiModality Workplace can be configured with different combinations of clinical applications. syngo applications can be added to the multimodality workplace either individually or as clinically focused packages.
The syneo MultiModality Workplace is a medical diagnostic workplace for realtime viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syrgo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XPbased software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software. The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
Technological Characteristics: .
The syngo MultiModality Workplace will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The syngo MultiModality Workplace 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.
. Substantial Equivalence:
The syngo Multimodality Workplace, addressed in this premarket notification, is substantially equivalent to the following commercially available device:
syngo MultiModality Workplac (K052775) MAGNETOM Systems with Expert-i option (K052423)
The syngo MultiModality Workplace described in this premarket notification has the same intended use and similar technical characteristics as the devices listed above.
In summary, Siemens is of the opinion that the syngo MultiModality Workplace does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 27 2006
Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc., TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K061964
Trade/Device Name: syngo MultiModality Workplace (MMWP) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 5, 2006 Received: July 12, 2006
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, 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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the letters "FDA" in a bold, sans-serif font. Underneath the letters is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
oting Public .
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/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
Enclosure
4
Section 1: Indications for Use
Indications for Use
| 510(k) Number (if known): | K06 1964 |
|---|---|
| Device Name: | syngo MultiModality Workplace (MMWP) |
Indications for Use
The syngo MultiModality Workplace is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syngo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XP-based software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
(Please do not write below this line - continue on another page if needed) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V OR Over-The-Counter Use (Per 21 CFR 801.109)
| June 24th, 2006 | CONFIDENTIAL | Page 6 |
|---|---|---|
| ----------------- | -------------- | -------- |
(Division Sign)
Division
and
| 510(k) Number | KC61964 |
|---|---|
| --------------- | --------- |