510(k) Report

Devices descending from K011142

211 later devices reach Aquarius Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K250039HPACSHealthhub20250—
+11K243069Lumys (V1)Intradys20250—
+11K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+11K231683inHEART ModelsInheart, Sas20240—
+11K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+12K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+12K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+13K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+13K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+14K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+14K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—