510(k) Report

Devices descending from K043092

13 later devices reach Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141293Phot-X Iis Model 505Takara Belmont Corporation20140—
+1K120318Vivi Ergon-X HFVivi S.R.L.20127—
+1K111330Air Techniques High Frequency Intra-Oral X-RaySkanray Technologies20111—
+1K103579Intra Skan DCSkanray Technologies20112—
+1K083344Heliodent PlusSirona Dental Systems GmbH20089—
+2K170967Intraskan DC PlusSkanray Technologies Private Limited20170—
+2K163519RX DCCefla S.C.20174—
+2K130109Endograph DCVilla Sistemi Medicali S.P.A.20131—
+3K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L.20230—
+3K182206RiX70 DCTrident S.R.L20183—
+4K232085Dvas (Dvas-M, Dvas-W)Genoray Co., Ltd.20230—
+4K211014PortraySurround Medical Systems20211—
+5K223780Lumos 3DX3Dio20230—