510(k) Report

Devices descending from K160334

2 later devices reach Advanced Medical Imaging Software Suite (KSWVWR) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211655aPROMISEExini Diagnostics AB20211—
+2K220590aPROMISE XExini Diagnostics AB20220—