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.

Regards,

Terry, Director of Marketing, Ziosoft, Inc.

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