510(k) Report

Devices descending from K063539

75 later devices reach Nordic Image Control and Evaluation (Nice) Software, Version 2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083491NeuroscapeOlea Medical20090—
+1K082441Nordicice SoftwareNordicimaginglab AS2008732
+2K090546Modification to Nordicice SoftwareNordicimaginglab AS200972—
+3K212720nordicDSCNordicneurolab AS20222—
+3K163324nordicBrainExNordicneurolab AS20175—
+3K133910NordicbrainexNordicneurolab201452
+3K130278MR PermeabilityPhilips Medical Systems Nederland B.V.20131—
+3K123306Nordic TumorexNordicneurolab201301
+3K123302IB ClinicImaging Biometrics, LLC20131—
+3K120196Olea SphereOlea Medical201251—
+3K111161Perfscape V2.0Olea Medical201153—
+3K092102Nordicbrainex Software, Version 1.0Nordicimaginglab AS200901
+4K243209nordicMEDiVANordicneurolab AS20240—
+4K241608nordicMEDiVANordicneurolab AS20241—
+4K221426Functional MR V1.0Olea Medical S.A.S.202201
+4K211356GIQuantMotilent, Ltd.20210—
+4K202808Brainance MDAdvantis Medical Imaging Single Member P.C.20211—
+4K171754NovaPACSNovarad Corporation201741
+4K153103CARESTREAM Vue PACSCarestream Health, Inc.201601
+4K143368GenIQGe Medical Systems, LLC20150—
+4K132095Olea SphereOlea Medical201320—
+4K121447Ischema View RapidIschemaview, Inc.201329—
+5K242709JLK-PwiJLK, Inc.20240—
+5K242556JLK-CTPJLK, Inc.20240—
+5K231662Aid-UIaid20241—
+5K231656Brainomix 360 e-MRIBrainomix Limited20230—
+5K223555Brainomix 360 e-CTPBrainomix Limited20230—
+5K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+5K213891RealNowYiwei Medical Technology Co., Ltd.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K220663AccuCTPArteryFlow Technology Co., Ltd.20221—
+5K192912AutoMIStarApollo Medical Imaging Technology Pty., Ltd.20190—
+5K180161Viz CTPViz. Ai, Inc.20182—
+5K172477iSchemaView RAPIDIschemaview, Inc.201817—
+5K161601DynamikaImage Analysis Limited20170—
+5K152602Olea Sphere V3.0Olea Medical201617—
+6K250039HPACSHealthhub20250—
+6K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+6K243069Lumys (V1)Intradys20250—
+6K231353AccuCTP ProArteryFlow Technology Co., Ltd.20230—
+6K223091CT Perfusion V1.0Olea Medical20230—
+6K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+6K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+6K211059CereFlow™ V1.2Translational Mri, LLC20231—
+6K221627PerfusionGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+6K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+6K212565CoverScan v1Perspectum, Ltd.20221—
+6K202793Cercare Medical NeurosuiteCercare Medical Aps20213—
+6K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+6K192692Brainomix 360 e-CTABrainomix Limited20203—
+6K192962icobrain-ctpIcometrix NV20200—
+6K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+6K182130iSchemaView RAPIDIschemaview, Inc.20189—
+6K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+6K170580Carestream Vue PACSCarestream Health, Inc.20171—
+7K253794Prostate CoreLucida Medical, Ltd.20260—
+7K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+7K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+7K241975Serv Medical CDSSServ Medical Pte., Ltd.20250—
+7K242123Brainomix 360 e-CTABrainomix Limited20250—
+7K231570StrokeViewer PerfusionNico-Lab B.V.20230—
+7K230016Cercare Medical NeurosuiteCercare Medical A/S20232—
+7K213986CerebralGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+7K230294CoverScan (CoverScan v1.1)Perspectum20230—
+7K213165RapidIschemaview, Inc.20227—
+7K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K252526Rapid DeltaFuseIschemaview, Inc.20250—
+8K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+8K233582RapidIschemaview, Inc.20243—
+8K233512Rapid (6.0)Ischemaview, Inc.20241—
+9K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+9K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+9K243350Rapid Neuro3DIschemaview, Inc.20251—
+10K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—