iPhone medical image viewers–devices or not?

Back in January, the FDA decided that an iPhone image viewer diagnostic application, Mobile MIM from MIMvista, was a class III medical device requiring pre-market approval.  Other similar medical image viewers have been waiting for an FDA knock on the door.  According to this report in FierceMobileHealthcare, they are still waiting.  Size and resolution have been the major barriers to wider use….but here comes the iPad.