510(k) Report

Devices descending from K945428

208 later devices reach Scribe (TM) Diagnostic Imaging Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation20210—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+12K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+12K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—