510(k) Report

Devices descending from K123381

11 later devices reach Hyperion X9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161900Hyperion X5Cefla S.C.20160—
+1K160166X-MIND triumDe Gotzen S.R.L.20163—
+1K152162Myray- HYPERION X5Cefla S.C.20151—
+1K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+2K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+2K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+2K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+2K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation20200—
+2K191719X-MIND TriumDe Gotzen S.R.L.20200—
+2K151137X-View, ImagenEdlen Imaging, LLC20160—
+3K250060GT300; GT300-CGenoray Co., Ltd.20250—