Sure viewing a scanned paper document should not be under the FDA regs. But if the device is used for clinical interpretation, wouldn't a practicing clinician want to use a FDA approved device? Camera taking pictures of things probably doesn't need FDA approval for example in anatomic pathology or dermatology. But what about devices that provide enhancements or require a Dicom viewer? If I was a practicing clinician I would want some assurance that my use of a medical device would not be questioned if I was involved in litigation. Obviously my interpretations are subject to scrutiny. But I can see it now. A lawyer finds out you made a medical decision using a non-FDA approved device and spins it all negatively from that point on. As Greg has stated several times, a Dicom viewer is way overkill for viewing photographs and scanned documents.
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