Ziosoft Comments

Ziosoft has chimed in on the great FDA approval debate:

Hi Dr. Dalai,

In response to your posting on November 12, 2009, in order to be “FDA-cleared” for PRIMARY 2D diagnostic review in the US, I believe FDA mandates certain image display specifications such as loss-less image quality, minimum monitor resolution and DICOM monitor calibration. In this case, most PACS companies are in compliance if they position their systems as a PRIMARY 2D viewer whether it be local or remote.

However, if you are referring to FDA clearance for 3D diagnostic review systems, a 3D company only needs to show substantial “intended-use” equivalence of their system (and associated applications) to an existing predicate regardless if the system is used locally or remotely. Our Ziostation system has been FDA-cleared since 2007. FDA does not place any stipulations on display specifications since 3D is considered a SECONDARY diagnosis review application. In other words, dedicated 3D companies can use non-DICOM calibrated monitors, at any resolution. This is why any standard monitor can be used for 3D.

In Japan, our Ziostation system is used for both 3D and as a 2D viewer for primary diagnosis. Therefore, even though the Ziostation is positioned as primarily a 3D system in the US market, our system was architected to provide full loss-less image fidelity, using a true unified thin-client system. The functionality and image integrity are equivalent whether used locally or remotely.

I hope this provides some insight into this topic.

By the way, our zioTerm free 2D/3D application has been officially released (see attached press release). If you feel this would be of value to your readers, feel free to mention it in your blog.


Terry, Director of Marketing, Ziosoft, Inc.

Comments, GE? Comments, Tera?

Siemens’ Viable Alternative

Break out the caviar! Brought to you via DoctorDalai.com, with only a minimal degree of joviality, here’s a little preview of Siemens’ enviable new offering at RSNA, based on the new syngo.x platform:

It’s WAY too early to have a real name for this, but you don’t need to drive over a viaduct to get here. It might even be visible on your VIAO. Hopefully, you won’t need any Viagra to enjoy the experience.

I’ve had a brief close-up preview myself, as the second test installation (it’s not yet on our production side) of the new system was just completed at our Agfa hospital. The integration with IMPAX seems to work well, which was no trivial feat of conviviality. What we have is a server providing a thin-client 3D application, launched from the IMPAX viewer. Right now, we have the basic tools, with VR, MPR, etc. However, I was shown previews of the more advanced functions that hint at a level of automation that could make this product the leviathan to beat in this space. The Siemens RSNA Preview page suggests an enterprise-wide syngo.x global, uniform application the size of Bolivia. In particular, this new standard is set to give us the next generation of Siemens PACS:

Can I have my images automatically opened in 2D, 3D and 4D?

The new PACS solution* combines 2D, 3D, and 4D reading – enabling fast reading in any dimension – together in one place. The system features case-specific reading, automatically knowing when to call up specific applications. It remembers users’ preferences, sorts images accordingly, and allows users to adapt reading tools and layouts to their needs. Due to its flexibility and minimal hardware requirements, existing hardware can be leveraged and storage capacity can be easily added.

* The information about this product is being provided for planning purposes. The product is pending 510(k) review, and is not yet commercially available.

Sounds a little like Amicas 6.0.

Anyway, there’s more to come! Hopefully, I won’t be accused of bloviating.

Visage Responds

I raised the question prompted by GE’s claim about the approval or lack thereof first with some of the principals of Visage and Promedicus whilst at RANZCR. It was their opinion that their product was indeed kosher, if I might use that term. Malte W., the CTO of Visage, sent this response to my recent post:

Dear Dr. Dalai:

On behalf of Visage Imaging I would like to respond to the points you have raised in your posting of November 12, 2009.

The Visage PACS/CS system is cleared by the FDA for the purpose of diagnostic viewing. The ‘Intended Use’ as shown on the FDA web site includes reviewing of medical images, both locally as well as remotely and in distributed environments.

As your blog so effectively demonstrates we now live in a world where nothing is remote and “remote review” should not be a compromised special case. Therefore the Visage product line expands beyond traditional system boundaries by providing a single platform that combines traditional PACS functionality and advanced visualization in a truly integrated fashion. Visage allows for full fidelity diagnostic reading, both locally as well as over the network. It offers basic to advanced image access and image manipulation to your referrers, all on the same platform.

Visage Imaging’s R&D team has continuously improved the technology to optimally exploit slow networks for diagnostic image viewing at the highest possible image fidelity. In the end, the outcome is what really matters for the actual user. That is, how fast is the system in all the relevant network scenarios, how easy is it to use, does it have all the required features? For primary interpretation image quality must be uncompromised. In other situations it may be desirable not to wait for a full fidelity image if a compressed image is availably more quickly. Visage supports both.

In the end users should judge by themselves which of the “smart” technologies meets their requirements best. Visage Imaging is looking forward to continuing the discussion at RSNA and invites everyone who is interested to take a look at the Visage solution. Please come to the Visage Imaging booth #8320 (Hall B) and judge for yourself what levels of versatility, quality, and performance the Visage platform provides.

Yours truly,

Malte W.,
Chief Technology Officer, Visage Imaging

I have yet to hear from the rest of the vendors in question. Thanks for your response, Malte. Sadly, I won’t make it to RSNA, but I hope to learn more about Visage 7 soon!


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….

"The Only FDA Approved Remote Review System"

You might recall the “shootout” between Visage and TeraRecon we held here a few months ago. GE could not attend due to timing conflicts, but later held a separate demonstration of their AW Server system at our site. In brief, this is a thin-client version of the venerable AW software, which allows remote access to high-level processing capabilities. The system works well, especially for those who like the GE/AW approach to such things. It has a lot of power, but doesn’t quite have the level of automation that was demonstrated by TeraRecon.

Our GE rep, of whom I’m far more of a fan than of the company itself, sent us these bullet points about the AW Server:

Designed with you…

  • Enhanced work flow tools for ultimate reading and collaboration
  • Easily track workflow status with custom work lists and filters
  • Switch between exams instantly to minimize interruptions
  • Easy access to all prior exams in the work list for quick comparisons

Beyond the walls…..

Diagnostic reads with Exclusive “Smart Compression” technology….Accessibility anywhere, anytime

  • Removes constraints on needing physical access to a workstation…Convert any PC to a high end, post processing workstation
  • Total thin Client solution
  • Only FDA approved Remote Review System
  • Unique “Smart Compression” Technology
  • One click to apply compression only during interaction
  • Compression “smartly” turns off when the mouse is released
  • Automatically display full fidelity static, high quality images for diagnosis!
  • Works over any network condition…from any location

Secure the future…

Seamless integration with the security and service features facilities need…Maximize investment

Of these claims, clearly the statement “Only FDA approved Remote Review System” catches the eye. I did a double-take on this, both when I read the e-mail, and when it was stated in the demonstration. This seems to be a rather bold statement on the surface, and I thought I should probably pursue it further. So, whilst at RANZCR, I asked the president of Promedicus, the company that owns Visage, if he was aware of this. He thought the statement was incorrect, and assumed that Visage, TeraRecon, and other similar products were all approved in the U.S. Curiouser and curiouser.

There was nothing left to do but ask GE directly, which I did via email. The answer came with an attached market clearance document from the FDA, although not quite the one that is found on the FDA website. The publicly available document is found HERE, and differs from the document GE sent me in its opening pages. The FDA’s version has some different cover-sheets which we will discuss in a minute. The salient point from GE is found on the last page:

The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

Italics are mine. The interpretation of this line is that one should only be diagnosing from full-fidelity images, and not lossy-compressed images. (Lossless compressed images are a no man’s land, I guess.) GE’s approach is something called “Smart Compression” as seen in their AW Server brochure below on page 4. (Sorry about the Scribd embedding, but I could not find the same brochure online.)

The important line reads:

Exclusive “Smart Compression” technology dynamically speeds you through the case – even at low bandwidths – so you can quickly view full fidelity, static images for instant diagnoses.

All this was reviewed in a conference call with several high-level folks in the AW division of GE Medical. This is the technology upon which they base the claim.

The approach is somewhat reminiscent of streaming technology as seen in Stentor and Dynamic Imaging PACS wherein the compressed images are around when you interact with the study, scroll, move around, whatever, but the full-fidelity image is displayed when you let up on the mouse. I assume GE’s software decompresses lossless-compressed images on-the-fly to satisfy the claim of presenting full-fidelity images. How this applies to a 3D volume rendering or a MIP series or whatever, I haven’t a clue.

The question now becomes, “What about the other guys?” What I’m going to do here is throw it open to any other vendor in this space that wants to respond with something I can post, and I will post it without editing or editorializing. I’m expecting responses from TeraRecon and Visage at the very least. Are you guys listening?

In the meantime, I did some additional digging over at the FDA.gov website. First, let’s look at TeraRecon’s 510(k) Premarket Notification, from December, 2005. Here are its indications for use:

The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.” The intended use of the device is to provide time-saving pre-processing of images to remove the need for an image review system to perform these activities while a user is waiting for processing to complete, to optimize the use of the user’s time.

The issue of using the thing for diagnosis really isn’t addressed directly; one assumes that the FDA’s permission to sell the device means we radiologists can actually use the device, I guess. And, they only discuss compression with respect to digital mammography.

When we look at the Visage 510(k) paperwork, things start to get a little murkier. Visage applied for approval for its PACS and CS (advanced visualization) software in one bundle.

Intended Use

Visage PACS/CS is a system for distributing, viewing, processing, and archiving medical images within and outside health care environments.

The Visage PACS/CS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations.

Visage PACS/CS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnoses, however, resides with the doctors and/or their medical staff in their own area of responsibility.

Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws.

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis.

Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

It sounds to me like Visage has the same approval level. By the way, I’ve come to the realization that the indications here, as for the AW and TeraRecon, are written by the companies themselves, and approved by the FDA. That does help somewhat in the interpretation, doesn’t it?

Which brings us back to the cover letter of the AW Server 510(k) application from the FDA. It includes the following:

AW Server is substantially equivalent to the devices listed below:

Model: Advantage Workstation 4.3
Manufacturer: General Electric Medical Systems
510 (k): K052995
Classification name: PACS per 21 CFR 892.2050
Regulatory Class: II
Product Code: LLZ

Model: AquariusNET Server
Manufacturer: TeraRecon, Inc.
510 (k): K012086
Classification name: PACS per 21 CFR 892.2050
System, Image Processing per CFR 892.2020
Regulatory Class: II
Product Code: 90-LLZ, 90-LMD

And that’s what GE said about the AW Server! In this section of this letter, the Indications for Use are as follows:

AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.

The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, rained physicians ay use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

Remember, GE wrote these specs, and the government approved them. Reading this paragraph makes the question of what is allowed for diagnosis and what is not even less obvious.

I understand where GE is coming from with their claim, and I like the “Smart Compression” approach. Still, the claim to be the “only FDA approved remote review system” is very bold. If true, and if it stays true, I’ll very strongly consider purchasing the AW Server, if and when I get the cash to do so.

Again, I invite the commentary of the other major players in this space. What say you?

PACS Loses One Of Its Own

I noted a significant spike in blog traffic this morning related to Sectra and sadly there was a tragic reason behind it. PACS has lost a true gentleman, Dr. John Goble, head of Sectra’s North American operations. From the Sectra press release:

Shelton, CT – November 9, 2009 – Dr. John Goble, President of Sectra’s North American medical business was tragically killed in a helicopter accident in the vicinity of Adelanto Airport, CA, USA. Dr Goble, age 58, had led Sectra’s medical operations in the US since 1997.

”This is very sad news for all of us at Sectra. John Goble has been a strong and committed leader of our North American business for the past 12 years. John was a great person to work with, a close friend, as well as a very competent colleague, but most of all he was a loving husband, brother and son. Our thoughts and deepest sympathies go out to his family and friends in this moment”, says Dr Torbjörn Kronander, President of Sectra Medical Systems.

Sectra has appointed Tom Giordano, as acting President of Sectra North America. Tom Giordano, former Vice President, Marketing of Philips North America, has worked in executive positions at Philips Medical Systems since 1977. Since 2005 Tom Giordano has been a Sectra North America board member and management consultant and has a deep understanding of Sectra North America’s business and operations.

“In the midst of these very sad circumstances, we are grateful for having with us such an experienced leader and medical imaging professional as Tom Giordano. We will continue to serve our North American customers with the same commitment to excellence, under Tom’s leadership,” Torbjörn Kronander adds.

One of Dr. Goble’s loves was flying a vintage helicopter, according to the LA Times:

A 1951 military helicopter that crashed and killed all three men aboard it Saturday was headed to an aircraft-and-classic car show honoring U.S. veterans at the Flabob Airport in Riverside, the event’s director said.

The twin-rotor Piasecki PV-18 helicopter had been booked to appear as a non-flying display through Classic Rotors, a rare and vintage rotorcraft museum in Ramona, show director Jon Goldenbaum said Sunday.

The museum was closed Sunday night and a message left on it answering machine was not immediately returned.

Federal Aviation Administration officials said the vintage helicopter struck power lines shortly after taking off from Adelanto Airport about 8:30 a.m. Saturday.

I had met Dr. Goble only once, whilst visting the Sectra RSNA booth with Mike Cannavo. Dr. Goble impressed me as someone more of us in the business could emulate. Perhaps you recall how he handled Sectra being dumped as Philips’ PACS product in favor of Stentor, as sent to AuntMinnie, and lifted for my blog:

Sectra has been in the US for nearly ten years, and we have a superb service and support team. In addition to Philips Medical Systems, we provide Level II support for our other partners, selected dealers and comprehensive support for our direct sales.

Our PACS products for the Orthopedics and Mammography markets are extremely well received by the US market. While Philips’ acquisition of Stentor will undeniably impact our revenue in the short term, we intend to aggressively bid for service on our products and continue to protect the investment of customers who have purchased Sectra PACS… whether under the Philips label or directly from us.

Sectra will continue to innovate and bring industry leading products to market in the US. If you have questions about support for your system, extensions to your Sectra PACS or have a new opportunity, we’d be happy to talk with you.

John Goble, Ph.D., President, Sectra North America, Inc. Call us at 800.——–.

Many would have bemoaned the apparent betrayal, but Dr. Goble went on doing what he did best, taking care of his customers.

He will be missed.