510(k) Report

Devices descending from K090279

17 later devices reach Sedecal, Millennium Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsSedecal., Sa.20210—
+1K182134ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20181—
+1K133782Nova FA DR SystemSedecal., Sa.2014111
+1K121345SR Suite 1.0Halifax Biomedical, Inc.20121—
+2K202388Apolo D / Apolo SVmi Tecnologias Ltda20200—
+2K202293Radiographic System Challenge XSedecal., Sa.20200—
+2K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20200—
+2K182880Halifax Imaging KitHalifax Biomedical, Inc.20180—
+2K173953uDR 780iShanghai United Imaging Healthcare Co., Ltd.20182—
+2K150816Jumong SeriesSg Healthcare Co, Ltd.20152—
+2K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA20152—
+3K241068uDR 780iShanghai United Imaging Healthcare Co., Ltd.20241—
+3K230241Jumong GeneralSg Healthcare Co, Ltd.20230—
+3K190601MasteRad MX30Medicatech USA20190—
+3K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+3K151219Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBeijing Polycon Medical Engineering Company20150—
+4K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.20250—