510(k) Report

Devices descending from K093683

21 later devices reach Orthopantomograph OP300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122806Image Works PanouraMic International20132—
+1K122018OP300Palodex Group OY20128—
+1K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+2K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+2K133544OP300Palodex Group OY20147—
+2K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+2K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+3K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+3K180947Orthopantomograph OP 3DPalodex Group OY201821
+3K171012Veraview X800J. Morita USA, Inc.20171—
+3K163423Orthopantomograph OP300Palodex Group OY201721
+3K170813Orthopantomograph OP 3DPalodex Group OY201701
+3K161881PreXion3D ExcelsiorPrexion Corporation20162—
+3K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+4K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+4K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+4K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+4K173878PreXion3D ExcelsiorPrexion Corporation20181—
+5K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+5K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+5K181983PreXion 3D ExcelsiorPrexion Corporation20180—