510(k) Report

Devices descending from K052632

117 later devices reach VITREA2 Version 3.8 Medical Image Processing Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231662Aid-UIaid20241—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K220039AutoSegAi Medic, Inc.20221—
+7K220727inHEART MODELSInheart, Sas20221—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K250039HPACSHealthhub20250—
+8K243069Lumys (V1)Intradys20250—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K231683inHEART ModelsInheart, Sas20240—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—