510(k) Report

Devices descending from K001439

39 later devices reach Orthoceph OC100 D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073365Dental Digital X-Ray Imaging SystemVATECH Co., Ltd.20081—
+1K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division200510—
+1K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp.200324—
+1K021372Veraviewepocs Panoramic X-Ray Unit with Cephalometric CapabilityJ. Morita USA, Inc.20020—
+2K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd.20146—
+2K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp.201312
+2K101661Myray HyperionCefla Dental Group20100—
+2K100317Digital X-Ray Imaging System (Pax-Primo) Model Pax-PrimoVATECH Co., Ltd.20100—
+2K073696VeraviewepocsJ. Morita USA, Inc.200822—
+2K053220Veraview IC 5, Model XDP1J. Morita USA, Inc.20060—
+3K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.20220—
+3K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation20200—
+3K150354PAPAYA 3D PlusGenoray Co., Ltd.20154—
+3K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—
+4K220392PAPAYA 3D & PAPAYA 3D PlusGenoray Co., Ltd.20220—
+4K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.20201—
+4K151137X-View, ImagenEdlen Imaging, LLC20160—
+4K122806Image Works PanouraMic International20132—
+4K122018OP300Palodex Group OY20128—
+4K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+5K250060GT300; GT300-CGenoray Co., Ltd.20250—
+5K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+5K133544OP300Palodex Group OY20147—
+5K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+5K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+6K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+6K180947Orthopantomograph OP 3DPalodex Group OY201821
+6K171012Veraview X800J. Morita USA, Inc.20171—
+6K163423Orthopantomograph OP300Palodex Group OY201721
+6K170813Orthopantomograph OP 3DPalodex Group OY201701
+6K161881PreXion3D ExcelsiorPrexion Corporation20162—
+6K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+7K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+7K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+7K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+7K173878PreXion3D ExcelsiorPrexion Corporation20181—
+8K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+8K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+8K181983PreXion 3D ExcelsiorPrexion Corporation20180—