(27 days)
Not Found
No
The summary describes a standard PACS system with image management, viewing, and reporting features, with no mention of AI or ML capabilities.
No
The device is a PACS system for managing, displaying, and archiving medical images, and generating reports, which are diagnostic functions, not therapeutic.
Yes
The device is a PACS system that allows for "review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports." The generation of diagnostic reports indicates that it is used in the diagnostic process.
Yes
While the primary offering is a turn-key system with pre-installed software on OEM hardware, the description explicitly states that version 5.0 offers an optional "software only" workplace delivered on CD-ROM for installation on the end user's own computer hardware. This optional configuration qualifies as a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that syngo® Dynamics is for the "acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation." This focuses on managing and processing medical images, not on analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The description reinforces this by explaining that the system receives, stores, distributes, and archives images from imaging devices like ultrasound and x-ray machines. It also mentions reviewing, editing, manipulating image data, and generating reports, all of which are related to image management and interpretation, not in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or performing tests on samples outside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. syngo® Dynamics deals with medical images, which are generated by imaging modalities, not from biological samples.
N/A
Intended Use / Indications for Use
syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Product codes
LLZ
Device Description
This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 5.0.
syngo® Dynamics is a digital image management system that includes a DICOM server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.
synad® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to host additional 3rd party software applications.
syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.
Version 5.0 contains extended reporting features to address a broader range of diagnostic imaging needs and other added capabilities for Radiology and Obstetric imaging, while continuing to provide special focus on Cardiology needs including echocardiography, x-ray anqiography, and image storage for nuclear medicine.
synqo® Dynamics, version 5.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware.
Mentions image processing
Not Found
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
Not Found
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
510(k) Summary
syngo® Dynamics (version 5.0)
Date of Summary Preparation: [Date]
This summary of 510(k) safety and effectiveness information is being This Submitted in accordance with the requirements of 21 CFR §807.92.
General Information 1.
Specification Developer and Manufacturer Name and Address
Siemens Medical Solutions, Inc. 400 W. Morgan Road, Suite 100 Ann Arbor, MI 48108
Establishment Registration Number
1836549
Contact Person 2.
Ludmilla Foubert Sr. Manager, Regulatory Affairs and Quality
| Telephone: | (610) 219-5373 |
|---|---|
| Fax: | (610) 219-1521 |
| email Address: | ludmilla.foubert@siemens.com |
Device Name and Classification 3.
| Trade Name: | syngo® Dynamics
Version 5.0 |
|-----------------------|---------------------------------------------|
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
.. . .
1
4. Device Description
This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 5.0.
syngo® Dynamics is a digital image management system that includes a DICOM server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.
synad® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to host additional 3rd party software applications.
syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.
Version 5.0 contains extended reporting features to address a broader range of diagnostic imaging needs and other added capabilities for Radiology and Obstetric imaging, while continuing to provide special focus on Cardiology needs including echocardiography, x-ray anqiography, and image storage for nuclear medicine.
synqo® Dynamics, version 5.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware.
5. Intended Use
svngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
6. Substantial Equivalence
The syngo® Dynamics, addressed in this premarket modification, is substantially equivalent to the following commercially available devices:
| Predicate Device Name and | 510(k) | Clearance | Product |
|---|---|---|---|
| Manufacturer | Number | Date | Code |
| KinetDx | |||
| Siemens Medical Solutions, Inc | K041029 | 07/05/2004 | LLZ |
CONE:DENTIAL
2
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance
Date | Product
Code |
|--------------------------------------------------------------------------------------|------------------|-------------------|-----------------|
| VERICIS Cardiovascular Image and
Information System
Camtronics Medical Systems | K051649 | 08/02/2005 | LLZ |
| AscentiaTM (formally EncompassTM)
Heartlab Inc | K050228 | 02/18/2005 | LLZ |
Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device
syngo® Dynamics is a software device that is shipped as a turnkey system with syngo@ Dynamics is a bonthan off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.
syngo® Dynamics, version 5.0 also offers an optional "software only" workplace Syngo® Dynamics, version 3.0 also on on will be delivered on CD-ROM and with full viewing and report generation, when computer hardware. This software-only installed by the cha ason on his the customer's computer hardware meet defined requirements.
synqo® Dynamics servers use the Microsoft Windows 2003 Server operating syngo® Dynamics Servere ase the Microsoft Windows XP operating system.
The herewith described syngo® Dynamics supports DICOM-formatted images and structured report objects.
General Safety and Effectiveness Concerns 8.
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device.
Risk management is ensured via a risk analysis, which is used to identify potential hisk management to onsared have are controlled via software development and hazards. Those potonial hazarsa To minimize electrical, mechanical and vellication and valiation toot.hg. To recognized and established industry practices and standards.
3
Conclusion as to Substantial Equivalence ರು.
In summary, Siemens is of the opinion that syngo@ Dynamics does not introduce In summary, Slemens is of the opinion that Syngos Bynamouth.
any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.
R, L, L,
11/04/2005
Date
Date
Ludmilla Foubert Eudmilla Foubox
Sr. Manage, Regulatory Affairs and Quality
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 5 2005
Ms. Judith Campbell Regulatory Technical Specialist Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355
K053133 Re.: Trade/Device Name: syngo® Dynamics (version 5.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: November 4, 2005 Received: November 8, 2005
Dear Ms. Campbell:
We have reviewed your Section 510(k) premarket notification of intent to market the device estated in we have reviewed your Section 510(ts) premaintially equivalent (for the indications for use tated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regally marketed productions accessful with a mendments or to devices that have been May 26, 1978, the claculibilit dato of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provide of therefore, market the device, do not require approval of a provisions of the Act. The general controls provisions of the Act include subject to the general confors provisions of affects, 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 II your device is classified (see above) into exist regulations affecting your device can be found in the be subject to additional connolis. Entrolling in addition, FDA may publish further Oode of Peachar concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mar 127 's issualled on a saceaanna sight other requirements of the Act or any
FDA has made a determination that your device complies with other requirement Federal statutes and regulations administered by other Federal agencies. You must comply with all the line Federal statues and tegulations administered of other Fration and listing (2) CFR Part 807); tabeling Act sTequirements, melading, but not minication requirements as set forth in the quality systems (QS) (ZT CFR Part 801); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and consideration TRAC Coliner of unction of your device to a legally This letter will allow you to begin marketing your actives of your device of your device of your device to a legally
premarket notification. The FDA innder if your device an premarket notification. The FDA finding of substantial equivalion of your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r in the regulation of the filler following pumbers, based on the regulat If you desire specific advice for your device on our labeling regaration (1) vol
contact the Office of Compliance at one of the following numbers, based on the regulation num the top of this letter:
| 21 CFR 876.xxxx
21 CFR 884.xxxx
21 CFR 892.xxxx
Other | (Gastroenterology/Renal/Urology)
(Obstetrics/Gynecology)
(Radiology) | 240-276-0115
240-276-0115
240-276-0120
240-276-0100 |
| ---------------------------------------------------------------- | ---------------------------------------------------------------------------- | -------------------------------------------------------------- |
|---|
Also, please note the regulation while be reference to prematic notification" (21 CFR Also, please note the regulation entitled, " Misoralians on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsible in toll-free number (800)
Division of Small Manufacturers, International deco DIVISION of Binan 1443-6597 or at its Internet address 038-2041 of (2017) · 1301) · 1301) · 1301 · 1000 · 11:11 · 1
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): _ Ko23133 _______________________________________________________________________________________
Device Name: syngo® Dynamics (version 5.0)
Indications for Use:
syngo® Dynamics is a Picture Archiving and Communication System (PACS) Syngo® Dynamios is a Protate Kranker, display, storage, archive and manipulation informou for doosplanes, including quantification and report generation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
David G. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053133
Page 1 of 1
CONFIDENTIA!