510(k) Report

Devices descending from K120318

7 later devices reach Vivi Ergon-X HF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163519RX DCCefla S.C.20174—
+1K130109Endograph DCVilla Sistemi Medicali S.P.A.20131—
+2K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L.20230—
+2K182206RiX70 DCTrident S.R.L20183—
+3K232085Dvas (Dvas-M, Dvas-W)Genoray Co., Ltd.20230—
+3K211014PortraySurround Medical Systems20211—
+4K223780Lumos 3DX3Dio20230—