They weren't looking for level 1. With this technology, they knew it was level 3, thats why the scan was in different university hospitals for study, if the PMA is approval, they will definitely expand their study for the final FDA approval. Come on, this is Laser scanner, don't you know that the scientist and doctors expect this is level 3 device. Oh man, then you really need to study more about what is considered to be in those specific level.