510(k) Report

Devices descending from K061624

111 later devices reach Vitrea, Version 3.9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250039HPACSHealthhub20250—
+7K243069Lumys (V1)Intradys20250—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K231683inHEART ModelsInheart, Sas20240—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+10K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—