510(k) Report

Devices descending from K213504

6 later devices reach Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+1K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+2K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+2K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+3K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+3K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—