510(k) Report

Devices descending from K063826

86 later devices reach Syngo MI Applications 2007A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc.2008839
+1K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc.2007852
+2K131625Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions20130—
+2K131634SymbiaSiemens Medical Solutions USA, Inc.2013667
+2K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+2K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+2K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+3K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+3K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+3K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+3K142006Symbia 6.0Siemens Medical Solutions USA, Inc.2014659
+3K111445Discovery NM 630GE Healthcare20112Class I
+4K251153AuroraGe Medical Systems Israel20250—
+4K210173StarGuideGE Healthcare20211—
+4K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+4K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc.201763—
+4K162337Symbia 6.5Siemens Medical Solutions USA, Inc.201684
+4K121019Optima NM/CT 640GE Healthcare20120Class I
+4K113350Brivo NM 615GE Healthcare20110Class I
+5K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+5K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072
+5K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+5K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+6K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+6K241898Symbia SPECT and SPECT/CT SystemsSiemens Healthineers20240—
+6K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+6K210557Symbia VA10A FamilySiemens Medical Solutions USA, Inc.20214—
+6K190379MIM on LinuxMim Software, Inc.201914—
+6K182624MIM - MRT DosimetryMim Software, Inc.201853—
+7K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+7K223800MIM – Additional TracersMim Software, Inc.20231—
+7K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+7K220256MIM-AblationMim Software, Inc.20224—
+7K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc.202131
+7K203235VBrainVysioneer, Inc.20214—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+7K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+8K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+8K252922Neosoma Brain MetsNeosoma, Inc.20250—
+8K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+8K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+8K232514MIM – Dose AnalysisMim Software, Inc.20240—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K231102Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc.20232—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K212116VBrain-OARVysioneer, Inc.20211—
+8K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+8K202700ART-PlanTherapanacea20215—
+8K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+9K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+9K253835AffinityHermes Medical Solutions AB20260—
+9K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+9K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+9K242925MR Contour DLGE Healthcare20250—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20241—
+9K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+9K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+9K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+9K220813Art-PlanTherapanacea20224—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+10K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20260—
+10K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+10K251883MIM – LesionID ProMim Software, Inc.20250—
+10K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+10K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+10K230023ART-PlanTherapanacea Sas20233—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+11K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+11K232479ART-PlanTherapanacea20232—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+12K261306AI Contouring (VA10A)Varian Medical Systems20260—
+12K253078ART.1-USSeetreat Pty, Ltd.20260—
+12K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—