510(k) Report

Devices descending from K150595

8 later devices reach SCENARIA Phase 3 Whole-body X-ray CT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190841SCENARIA ViewHitachi Healthcare Americas20197—
+2K200498SCENARIA ViewHitachi Healthcare Americas20206—
+3K213829SCENARIA ViewFujifilm Healthcare Corporation202251
+4K231574Scenaria View 4.2FUJIFILM Healthcare Americas Corporation20234—
+5K250370SCENARIA View Phase 5.0Fujifilm Corporation20252—
+5K233583FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation20240—
+6K261229SCENARIA View Phase 6.0Fujifilm Corporation20260—
+6K253836FCT iStream Phase 2Fujifilm Corporation20260—