510(k) Report

Devices descending from K161748

11 later devices reach SUPRIA w/guideShot Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc.201710—
+2K171738Supria True64Hitachi Healthcare Americas Corporation20179—
+3K190841SCENARIA ViewHitachi Healthcare Americas20197—
+3K183291Supria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas201902
+4K200498SCENARIA ViewHitachi Healthcare Americas20206—
+5K213829SCENARIA ViewFujifilm Healthcare Corporation202251
+6K231574Scenaria View 4.2FUJIFILM Healthcare Americas Corporation20234—
+7K250370SCENARIA View Phase 5.0Fujifilm Corporation20252—
+7K233583FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation20240—
+8K261229SCENARIA View Phase 6.0Fujifilm Corporation20260—
+8K253836FCT iStream Phase 2Fujifilm Corporation20260—