510(k) Report

Devices descending from K945428

208 later devices reach Scribe (TM) Diagnostic Imaging Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K960911Netra Workstation System & Netra MD SoftwareScimage, Inc.1996207—
+2K073169Scimage PicomenterpriseScimage, Inc.20080—
+2K990426Calcium ScoringSiemens Medical Solutions USA, Inc.1999166—
+2K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems199833—
+2K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems199838—
+3K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20193—
+3K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+3K080575CORRIDOR4DMInvia200815—
+3K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C200745—
+3K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C2004112—
+3K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview200431—
+3K983392Data Ray Corporation DR11021 Medical Imaging MonitorData Ray19980—
+3K982820Barco Medis 5MP 5 Megapixel Medical Diagnostic Display SystemBarco NV Display Systems19980—
+3K982690Barco Medical Display Conformity and Consistency SoftwareBarco N.V.19982—
+4K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20202—
+4K172983HealthCCSZebra Medical Vision, Ltd.201814—
+4K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+4K101013Modification to Scintron IVMiegmbh20101—
+4K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+4K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+4K071331Vitrea Version 4.0Vital Images, Inc.2007821
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+4K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation200515—
+4K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd.200414—
+4K020073Medical AdministratorBarco N.V.20020—
+4K020058Medical LEBarco N.V.20020—
+5K2608794DMInvia, LLC20260—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—
+5K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+5K163071vascuCAPElucid Bioimaging, Inc.20173—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+5K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+5K131390Jusha-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20131—
+5K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+5K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+5K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+5K113620Myrian 1.11Intrasense20126—
+5K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+5K121023Spectrum V.0Intrinsic Medical Imaging20120—
+5K120207VISIAMeVis Medical Solutions AG20120—
+5K120484Visia OncologyMeVis Medical Solutions AG20128—
+5K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+5K101768Mie Scintron Gamma Camera SystemsMiegmbh20100—
+5K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+5K091001Myrian 1.4Intrasense20097—
+5K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+5K083691BonevueMicromri, Inc.20090—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+5K072821Vitrea 4DCTVital Images, Inc.2008171
+5K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+5K063066Axis-V Monochrome 5 MP DisplayNational Display Systems20070—
+5K071362Vital Connect 4.1Vital Images, Inc.2007113
+5K0632695MP Medical Monochrome Reference Display, Model MDM2010-5NCChi Lin Technology Co., Ltd.20071—
+5K071000MyrianIntrasense20078—
+5K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+5K0620545 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation20066—
+5K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+5K0614475M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd.200613—
+5K052120Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50Heeyoung Co., Ltd.20052—
+6K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K240786AutoChamberHeartLung Corporation20241—
+6K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+6K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+6K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+6K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+6K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+6K203256Imbio RV/LV SoftwareImbio, LLC202117—
+6K190868Cleerly LabsCleerly, Inc.20197—
+6K183012vascuCAPElucid Bioimaging, Inc.20182—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+6K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+6K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+6K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+6K150746JUSHA-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20150—
+6K150738VitreaViewVital Images, Inc.20158—
+6K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—