510(k) Report

Devices descending from K181804

2 later devices reach Alphenix, INFX-8000C/B, V8.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+2K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—