510(k) Report

Devices descending from K061284

31 later devices reach I-Cat Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+1K082410MASTER3DSE-Woo Technology20080—
+1K081847Picasso Master, Ect and Master 3DE-Woo Technology20080—
+1K073350Scanora 3DSoredex Palodex Group OY200724—
+2K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International20162—
+2K161881PreXion3D ExcelsiorPrexion Corporation20162—
+2K110839Scanora 3DSoredex Palodex Group OY20114—
+2K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—
+3K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+3K173878PreXion3D ExcelsiorPrexion Corporation20181—
+3K163423Orthopantomograph OP300Palodex Group OY201721
+3K130297Scanora 3DXPalodex Group OY20130—
+3K122806Image Works PanouraMic International20132—
+3K122018OP300Palodex Group OY20128—
+3K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+4K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+4K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+4K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+4K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+4K133544OP300Palodex Group OY20147—
+4K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+4K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+5K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+5K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+5K180947Orthopantomograph OP 3DPalodex Group OY201821
+5K171012Veraview X800J. Morita USA, Inc.20171—
+5K170813Orthopantomograph OP 3DPalodex Group OY201701
+5K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+6K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+6K2013783D Accuitomo 150NJ. Morita USA, Inc.20210—
+7K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—