510(k) Report

Devices descending from K182138

3 later devices reach Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+2K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+3K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—