510(k) Report

Devices descending from K102000

3 later devices reach Imagys through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+2K211655aPROMISEExini Diagnostics AB20211—
+3K220590aPROMISE XExini Diagnostics AB20220—