510(k) Report

Devices descending from K892358

137 later devices reach Pegasys Nuclear Medicine Imaging Computer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192277CardIQ FlowGE Medical Systems SCS20200—
+6K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+6K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+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
+7K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+7K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+7K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+7K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+7K230023ART-PlanTherapanacea Sas20233—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K200474Symbia 6.7Siemens Medical Solutions USA, Inc.202072
+7K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+8K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.20250—
+8K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+8K241898Symbia SPECT and SPECT/CT SystemsSiemens Healthineers20240—
+8K232479ART-PlanTherapanacea20232—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+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—
+9K261306AI Contouring (VA10A)Varian Medical Systems20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+9K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K212604Symbia VA10A FamilySiemens Medical Solutions USA, Inc.202131
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K231102Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc.20232—
+11K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20241—
+12K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…Siemens Medical Solutions USA, Inc.20260—