510(k) Report

Devices descending from K992385

14 later devices reach Orthopantomograph OP100D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+1K091866Progeny Vantage Panoramic X-Ray SystemMidmark20090—
+1K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division200510—
+2K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+2K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20146—
+2K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp.201312
+2K101661Myray HyperionCefla Dental Group20100—
+3K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.20220—
+3K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation20200—
+3K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+4K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+4K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+4K151137X-View, ImagenEdlen Imaging, LLC20160—
+5K250060GT300; GT300-CGenoray Co., Ltd.20250—