510(k) Report

Devices descending from K123509

14 later devices reach Scenaria Phase 2 Whole-Body X-Ray CT System through their predicates, nearest generation first.

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