510(k) Report

Devices descending from K051833

24 later devices reach TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner through their predicates, nearest generation first.

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