510(k) Report

Devices descending from K083510

15 later devices reach Kubtec Xpert 20 through their predicates, nearest generation first.

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