510(k) Report

Devices descending from K002519

271 later devices reach Vitrea 2, Version 2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+7K132853NovapacsNovarad Corp.201462
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+7K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K240620Cube NavigatorMedical Templates AG20240—
+8K230249IkshanaImmersivetouch20231—
+8K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K230023ART-PlanTherapanacea Sas20233—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K191530StoneCheckerImaging Biometrics, LLC20191—
+8K180867AmCAD-UOAmcad Biomed Corporation20180—
+8K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+8K160371NovaPACSNovarad Corporation20165—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K151233MonacoImpac Medical Systems, Inc.201569
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K232479ART-PlanTherapanacea20232—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K212896Visible Patient SuiteVisible Patient, Sas20213—
+9K202084DeepLook PRECISEDeeplook, Inc.20210—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K171754NovaPACSNovarad Corporation201741
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K233457RUSHutom, Inc.20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K231662Aid-UIaid20241—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K221796Cyware 4H and Cysart 4HAbys Medical20221—
+10K190178Monaco RTP SystemElekta, Inc.201945
+11K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+11K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K250039HPACSHealthhub20250—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K243069Lumys (V1)Intradys20250—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K223233Monaco RTP SystemElekta Solutions AB20231—
+14K252002Monaco RTP System (6.3)Elekta Solutions AB20260—