SYNGO DYNAMICS, VERSION 5.0

{0}------------------------------------------------ K053133 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<br>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<br>Siemens Medical Solutions, Inc | K041029 | 07/05/2004 | LLZ | CONE:DENTIAL {2}------------------------------------------------ | Predicate Device Name and<br>Manufacturer | 510(k)<br>Number | Clearance<br>Date | Product<br>Code | |--------------------------------------------------------------------------------------|------------------|-------------------|-----------------| | VERICIS Cardiovascular Image and<br>Information System<br>Camtronics Medical Systems | K051649 | 08/02/2005 | LLZ | | AscentiaTM (formally EncompassTM)<br>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<br>21 CFR 884.xxxx<br>21 CFR 892.xxxx<br>Other | (Gastroenterology/Renal/Urology)<br>(Obstetrics/Gynecology)<br>(Radiology) | 240-276-0115<br>240-276-0115<br>240-276-0120<br>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!