510(k) Report

Devices descending from K964746

3 later devices reach Hispeed CT/I with Performix Tube and Warp Scan Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012238DoserightPhilips Medical Systems North America Co.20010—
+1K973168Smartview Options for Hispeed CT/IGE Medical Systems19971—
+2K153429SmartView 3D OptionGe Hangwei Medical System Co., Ltd.20160—