510(k) Report

Devices descending from K953404

19 later devices reach Osteo-Ray 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc.200718—
+2K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.20210—
+2K200756Kubtec Mozart SupraKub Technologies, Inc.20201—
+2K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc.20193—
+2K173309Faxitron VisionCTFaxitron Bioptics, LLC20181—
+2K083510Kubtec Xpert 20Kub Technologies, Inc.200915—
+3K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.20210—
+3K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.20210—
+3K192939Volumetric Specimen ImagerClarix Imaging20190—
+3K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc.201114—
+4K182727Trident HD Specimen Radiography SystemHologic, Inc.20193—
+4K163052Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc.201711
+4K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC20124—
+5K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.20260—
+5K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd20202—
+5K183142PathVisionXLFaxitron Bioptics, LLC20190—
+5K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC20172—
+6K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,Ltd20230—
+6K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,Ltd20230—