510(k) Report

Devices descending from K031469

26 later devices reach Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C2003252
+2K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C200524—
+3K130960Suresubtraction OrthoToshibamedical Systems Corporation20133—
+3K083282Model TSX-301B Aquilion CT SystemToshiba America Medical Systems, In.C200818
+3K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C2008178
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K120546Aquilion PremiumToshiba Medical Systems Corporation, Japan201202
+4K112989Aquilion CXLToshiba America Medical Systems, In.C20120—
+4K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.2011153
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.201314—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.201611—
+6K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.201582
+6K150565Supria Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.20150—
+7K190841SCENARIA ViewHitachi Healthcare Americas20197—
+7K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc.201710—
+8K200498SCENARIA ViewHitachi Healthcare Americas20206—
+8K171738Supria True64Hitachi Healthcare Americas Corporation20179—
+9K213829SCENARIA ViewFujifilm Healthcare Corporation202251
+9K183291Supria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas201902
+10K231574Scenaria View 4.2FUJIFILM Healthcare Americas Corporation20234—
+11K250370SCENARIA View Phase 5.0Fujifilm Corporation20252—
+11K233583FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation20240—
+12K261229SCENARIA View Phase 6.0Fujifilm Corporation20260—
+12K253836FCT iStream Phase 2Fujifilm Corporation20260—