510(k) Report

Devices descending from K043612

10 later devices reach Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20146—
+1K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp.201312
+1K101661Myray HyperionCefla Dental Group20100—
+2K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.20220—
+2K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation20200—
+2K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+3K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+3K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+3K151137X-View, ImagenEdlen Imaging, LLC20160—
+4K250060GT300; GT300-CGenoray Co., Ltd.20250—