The FDA has actually cleared a couple of iPad apps for diagnostic viewing of radiological images; the ones I'm aware of are Nephosity and MobileMIM, and they ca

The FDA has actually cleared a couple of iPad apps for diagnostic viewing of radiological images; the ones I'm aware of are Nephosity and MobileMIM, and they can be used for x-ray, CT, PET, and MRI. I believe these are being cleared as Class II devices under the section 510(k) premarket notification process. Briefly, Class II devices include those that may be useful for diagnosis but aren't strictly necessary to sustain human life. The distinction has subtlety, so excuse the simplification. The 510(k) process has you explain that your "device" (hardware or software) fits into some existing category of medical device and is equivalent to those existing devices. It's not a particularly stringent process and generally doesn't require clinical trials. Note that in this case, "device" entails the iPad and app approved as a single item. So for radiology, certain setups have been cleared, yes. --- What's interesting is that on the pathology side, digital systems have not been cleared for primary diagnostic use, unlike in radiology. That means that a pathologist cannot diagnose a cancer based on a digital image of a biopsy alone. Indeed, the FDA has ruled that digital pathology systems are Class III medical devices (necessary to sustain human life) and thus require a premarket approval(PMA) process. Unlike 510(k) approval, PMA requires a clinical trial phase that can take years (and millions of dollars). While this seems arbitrary, there's actually decent logic to it: pathology often provides the last word in the diagnosis of many diseases, from malaria to cancers. The FDA is being very cautious, as compromised pathology work caused by unvalidated technology would directly impact patients.