510(k) Report

Devices descending from K001888

101 later devices reach Unicorn Model SYS0630 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140206Scintillation Gamma CameraDdd-Diagnostic A/S20141—
+1K031825C.CAMDanish Diagnostic Development A/S2003982
+2K161674QuantumCamDdd-Diagnostic A/S20160—
+2K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc.2007852
+2K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+2K060486Cyclone, Model Maicam 180Spectrica20060—
+3K131625Anyscan-S Spect Imaging SystemAbsolute Imaging Solutions20130—
+3K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc.2008839
+3K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+3K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+4K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+4K131634SymbiaSiemens Medical Solutions USA, Inc.2013667
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+4K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+4K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+4K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+4K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+5K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+5K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+5K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+5K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+5K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+5K142006Symbia 6.0Siemens Medical Solutions USA, Inc.2014659
+5K111445Discovery NM 630GE Healthcare20112Class I
+6K251153AuroraGe Medical Systems Israel20250—
+6K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+6K210173StarGuideGE Healthcare20211—
+6K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+6K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+6K162483Symbia Intevo BoldSiemens Medical Solutions USA, Inc.201763—
+6K162337Symbia 6.5Siemens Medical Solutions USA, Inc.201684
+6K121019Optima NM/CT 640GE Healthcare20120Class I
+6K113350Brivo NM 615GE Healthcare20110Class I
+7K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+7K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+7K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072
+7K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+7K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+8K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+8K241898Symbia SPECT and SPECT/CT SystemsSiemens Healthineers20240—
+8K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+8K210557Symbia VA10A FamilySiemens Medical Solutions USA, Inc.20214—
+8K190379MIM on LinuxMim Software, Inc.201914—
+8K182624MIM - MRT DosimetryMim Software, Inc.201853—
+9K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+9K223800MIM – Additional TracersMim Software, Inc.20231—
+9K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+9K220256MIM-AblationMim Software, Inc.20224—
+9K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc.202131
+9K203235VBrainVysioneer, Inc.20214—
+9K193252Contour ProtegeAIMim Software, Inc.20206—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+10K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+10K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+10K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+10K232514MIM – Dose AnalysisMim Software, Inc.20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K231102Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc.20232—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—
+10K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+10K213628VBrainVysioneer, Inc.20210—
+10K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+10K210632Contour ProtegeAIMim Software, Inc.20215—
+10K212116VBrain-OARVysioneer, Inc.20211—
+10K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+10K202700ART-PlanTherapanacea20215—
+10K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+11K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+11K253835AffinityHermes Medical Solutions AB20260—
+11K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+11K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+11K242925MR Contour DLGE Healthcare20250—
+11K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+11K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20241—
+11K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+11K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+11K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+11K220813Art-PlanTherapanacea20224—
+11K213976Contour ProtégéAIMim Software, Inc.20224—
+12K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20260—
+12K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+12K251883MIM – LesionID ProMim Software, Inc.20250—
+12K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+12K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+12K230023ART-PlanTherapanacea Sas20233—
+12K223774Contour ProtégéAIMim Software, Inc.20233—
+13K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+13K232479ART-PlanTherapanacea20232—
+13K231765Contour ProtégéAIMim Software, Inc.20232—
+14K261306AI Contouring (VA10A)Varian Medical Systems20260—
+14K253078ART.1-USSeetreat Pty, Ltd.20260—
+14K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+14K250035Contour ProtégéAI+Mim Software, Inc.20251—
+14K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—