510(k) Report

Devices descending from K162483

63 later devices reach Symbia Intevo Bold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072
+1K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+2K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+2K241898Symbia SPECT and SPECT/CT SystemsSiemens Healthineers20240—
+2K210557Symbia VA10A FamilySiemens Medical Solutions USA, Inc.20214—
+2K190379MIM on LinuxMim Software, Inc.201914—
+2K182624MIM - MRT DosimetryMim Software, Inc.201853—
+3K223800MIM – Additional TracersMim Software, Inc.20231—
+3K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+3K220256MIM-AblationMim Software, Inc.20224—
+3K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc.202131
+3K203235VBrainVysioneer, Inc.20214—
+3K193252Contour ProtegeAIMim Software, Inc.20206—
+3K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+3K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+4K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+4K252922Neosoma Brain MetsNeosoma, Inc.20250—
+4K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+4K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+4K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+4K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+4K232514MIM – Dose AnalysisMim Software, Inc.20240—
+4K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+4K231102Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc.20232—
+4K230082Auto SegmentationGe Medical Systems, LLC20231—
+4K221706AccuContourManteia Technologies Co., Ltd.20232—
+4K220630TorchTM SoftwareVoximetry, Incorporated20221—
+4K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+4K213628VBrainVysioneer, Inc.20210—
+4K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+4K210632Contour ProtegeAIMim Software, Inc.20215—
+4K212116VBrain-OARVysioneer, Inc.20211—
+4K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+4K202700ART-PlanTherapanacea20215—
+4K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+5K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+5K253835AffinityHermes Medical Solutions AB20260—
+5K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+5K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+5K242925MR Contour DLGE Healthcare20250—
+5K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+5K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20241—
+5K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+5K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+5K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+5K220813Art-PlanTherapanacea20224—
+5K213976Contour ProtégéAIMim Software, Inc.20224—
+6K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20260—
+6K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+6K251883MIM – LesionID ProMim Software, Inc.20250—
+6K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+6K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+6K230023ART-PlanTherapanacea Sas20233—
+6K223774Contour ProtégéAIMim Software, Inc.20233—
+7K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+7K232479ART-PlanTherapanacea20232—
+7K231765Contour ProtégéAIMim Software, Inc.20232—
+8K261306AI Contouring (VA10A)Varian Medical Systems20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+8K250035Contour ProtégéAI+Mim Software, Inc.20251—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K253270Contour ProtégéAI+Mim Software, Inc.20260—