510(k) Report

Devices descending from K081621

10 later devices reach Infx-8000C (Infinix CC-I and VC-I) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113052Infinix-CciToshiba America Medical Systems, In.C201171
+1K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+2K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+2K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+2K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+2K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+3K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+3K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+4K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+4K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117