510(k) Report

Devices descending from K192242

2 later devices reach Synergy Platform, Synergy, Infinity, VersaHD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+2K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—