It depends on whether they have a radiologist review the results for accuracy or not. If they don't then it is a diagnostic tool, and would need approval. If it

It depends on whether they have a radiologist review the results for accuracy or not. If they don't then it is a diagnostic tool, and would need approval. If it's just used to put higher priority patients in front of a radiologist sooner, and the radiologist does the diagnosing, then it might not need approval if they can show that the FDA has approved something similar in the past.