Friday, November 13, 2009


Whilst trolling for information about who is approved for what and who isn't, I stumbled across something quite interesting. It seems that Siemens is about to revamp its backbone software with a new version called "syngo.x". From the FDA 510(k) summary:

syngo.x 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.x based software options. syngo.x 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.

syngo.x is based on Windows. Due to special customer requirements and the clinical focus syngo.x can be configured in the same way as the syngo MultiModality Workplace with different combinations of syngo.x- 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.

svngo.x 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.

The Workflow Management enables by integration of any HL7- / DICOMcompatible RIS (IHE Year 5) to the syngo product family a consistent workflow - from patient registration to requirement scheduling to a personal work list and supports therefore reporting, documentation or administrative tasks.

Technological Characteristics:
syngo.x 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 Software will be installed by Siemens service engineers only.

The backend communication and storage solution is based on Windows 2008 operating system. The client machines are based on Windows XP. 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.x supports DICOM formatted images and

Sounds like a new edition of syngo is headed our way. We'll see it at RSNA, I assume....


Anonymous said...

I find the last two posts about Siemens and GE very interesting. More importantly it seems to point to what is "FDA 510(k)" certified relating to diagnostic Radiology. On a related topic of 510(k) I've wondered how this applies to Osirix? Aycan markets a 510(k) version of this software but what is the difference? Especially since the 510(k) documents clearly state that "It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application." My intent is not to post negative comments about Aycan, but more the system in which the FDA classifies PACS devices. Because for an end user, other than the 510(k) process applied for by Aycan, there is no difference in the open source software version of Osirix the version from Aycan.(Or I can't find clearly documented differences). But for a Hospital Administrator or IT Director, "FDA certified" is clearly the only option. Like to get your thoughts. Great blog, keep up the great work!

Anonymous said...

Is the any hard metrics requirements to the display of medical-images?

The FDA documents seem to contain lots of wording but isnt really clear on what the actual requirements are. Are there any? Any thoughts? References?

The term lossless is also some what misleading. The vendors label their products lossless when the image compression doesnt give rise to information loss, but this doesnt make the actual image display lossless. The information might already be lost prior to compression, or later on in the process of displaying the images.

As you mention its the vendors that pick the word - but how does the FDA control any of the pixels?