The machine is just off the shelf parts. The software is part of the approval. If you change it, all cases previously collected cannot be used. If software is changed AFTER APPROVAL, a PMA supplement needs to be filed.
If you look at the FDA warning letter to IMDS, IMDS was sanctioned for just such chicanery. They tried to submit clinical cases using multiple versions of the software. The FDA was PO'd to say the least
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