510(k) Report

Devices descending from K120196

51 later devices reach Olea Sphere through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153103CARESTREAM Vue PACSCarestream Health, Inc.201601
+1K132095Olea SphereOlea Medical201320—
+1K121447Ischema View RapidIschemaview, Inc.201329—
+2K242709JLK-PwiJLK, Inc.20240—
+2K242556JLK-CTPJLK, Inc.20240—
+2K231656Brainomix 360 e-MRIBrainomix Limited20230—
+2K223555Brainomix 360 e-CTPBrainomix Limited20230—
+2K213891RealNowYiwei Medical Technology Co., Ltd.20230—
+2K220663AccuCTPArteryFlow Technology Co., Ltd.20221—
+2K192912AutoMIStarApollo Medical Imaging Technology Pty., Ltd.20190—
+2K180161Viz CTPViz. Ai, Inc.20182—
+2K172477iSchemaView RAPIDIschemaview, Inc.201817—
+2K161601DynamikaImage Analysis Limited20170—
+2K152602Olea Sphere V3.0Olea Medical201617—
+3K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+3K231353AccuCTP ProArteryFlow Technology Co., Ltd.20230—
+3K223091CT Perfusion V1.0Olea Medical20230—
+3K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+3K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+3K211059CereFlow™ V1.2Translational Mri, LLC20231—
+3K221627PerfusionGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+3K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+3K212565CoverScan v1Perspectum, Ltd.20221—
+3K202793Cercare Medical NeurosuiteCercare Medical Aps20213—
+3K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+3K192692Brainomix 360 e-CTABrainomix Limited20203—
+3K192962icobrain-ctpIcometrix NV20200—
+3K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+3K182130iSchemaView RAPIDIschemaview, Inc.20189—
+3K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+3K170580Carestream Vue PACSCarestream Health, Inc.20171—
+4K253794Prostate CoreLucida Medical, Ltd.20260—
+4K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+4K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+4K241975Serv Medical CDSSServ Medical Pte., Ltd.20250—
+4K242123Brainomix 360 e-CTABrainomix Limited20250—
+4K231570StrokeViewer PerfusionNico-Lab B.V.20230—
+4K230016Cercare Medical NeurosuiteCercare Medical A/S20232—
+4K213986CerebralGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+4K230294CoverScan (CoverScan v1.1)Perspectum20230—
+4K213165RapidIschemaview, Inc.20227—
+4K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+4K201948AcroDTI VisualizerAcroviz, Inc.20200—
+5K252526Rapid DeltaFuseIschemaview, Inc.20250—
+5K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+5K233582RapidIschemaview, Inc.20243—
+5K233512Rapid (6.0)Ischemaview, Inc.20241—
+6K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+6K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+6K243350Rapid Neuro3DIschemaview, Inc.20251—
+7K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—