510(k) Report

Devices descending from K080211

17 later devices reach Model TSX-101A/H/I Aquilion 32/64 SP CT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112989Aquilion CXLToshiba America Medical Systems, In.C20120—
+1K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.2011153
+2K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.201314—
+3K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.201611—
+3K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.201582
+3K150565Supria Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.20150—
+4K190841SCENARIA ViewHitachi Healthcare Americas20197—
+4K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc.201710—
+5K200498SCENARIA ViewHitachi Healthcare Americas20206—
+5K171738Supria True64Hitachi Healthcare Americas Corporation20179—
+6K213829SCENARIA ViewFujifilm Healthcare Corporation202251
+6K183291Supria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas201902
+7K231574Scenaria View 4.2FUJIFILM Healthcare Americas Corporation20234—
+8K250370SCENARIA View Phase 5.0Fujifilm Corporation20252—
+8K233583FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation20240—
+9K261229SCENARIA View Phase 6.0Fujifilm Corporation20260—
+9K253836FCT iStream Phase 2Fujifilm Corporation20260—