FDA Approval

Conquest is open source and comes as is. It is NOT FDA approved.

Marcel

I've been struggling with the FDA approved rating for some time and am curious what the implications are. I'd love to find the information that clearly outlines the requirements for usage.

I justify using Conquest with 2 statements, 1.) because I am not manipulating the actual image (everything I do is uncompressed) then all I am doing is storing and routing images, and 2. what I am storing is temporary until I decide on a FDA approved PACS.

For me temporary could be 10 years and until that time, or unless there is some information that I clearly what I am doing is wrong, then I'll probably continue to do what I do.

Does anyone know what the effort is to get something FDA approved and if that effort is really is one of cost, I wonder if someone funded it, would Marcel consider that?

I don't think FDA approval is needed unless you do image manipulation. If you store images on Conquest as uncompressed I believe there is no FDA approval required. If you store images using compression then I think some approval is needed. (I do like the 10 year "temporary" installation idea though)

This is what I have heard from several people in the industry. Maybe someone has more info on this...