510(k) Report

Devices descending from K081624

13 later devices reach Infx-8000F (Infinix Csi and Infinix Dpi) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+1K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+2K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+5K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+6K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+6K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+7K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+8K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—