510(k) Report

Devices descending from K111161

53 later devices reach Perfscape V2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123306Nordic TumorexNordicneurolab201301
+1K120196Olea SphereOlea Medical201251—
+2K153103CARESTREAM Vue PACSCarestream Health, Inc.201601
+2K132095Olea SphereOlea Medical201320—
+2K121447Ischema View RapidIschemaview, Inc.201329—
+3K242709JLK-PwiJLK, Inc.20240—
+3K242556JLK-CTPJLK, Inc.20240—
+3K231656Brainomix 360 e-MRIBrainomix Limited20230—
+3K223555Brainomix 360 e-CTPBrainomix Limited20230—
+3K213891RealNowYiwei Medical Technology Co., Ltd.20230—
+3K220663AccuCTPArteryFlow Technology Co., Ltd.20221—
+3K192912AutoMIStarApollo Medical Imaging Technology Pty., Ltd.20190—
+3K180161Viz CTPViz. Ai, Inc.20182—
+3K172477iSchemaView RAPIDIschemaview, Inc.201817—
+3K161601DynamikaImage Analysis Limited20170—
+3K152602Olea Sphere V3.0Olea Medical201617—
+4K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+4K231353AccuCTP ProArteryFlow Technology Co., Ltd.20230—
+4K223091CT Perfusion V1.0Olea Medical20230—
+4K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+4K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+4K211059CereFlow™ V1.2Translational Mri, LLC20231—
+4K221627PerfusionGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+4K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+4K212565CoverScan v1Perspectum, Ltd.20221—
+4K202793Cercare Medical NeurosuiteCercare Medical Aps20213—
+4K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+4K192692Brainomix 360 e-CTABrainomix Limited20203—
+4K192962icobrain-ctpIcometrix NV20200—
+4K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+4K182130iSchemaView RAPIDIschemaview, Inc.20189—
+4K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+4K170580Carestream Vue PACSCarestream Health, Inc.20171—
+5K253794Prostate CoreLucida Medical, Ltd.20260—
+5K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+5K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+5K241975Serv Medical CDSSServ Medical Pte., Ltd.20250—
+5K242123Brainomix 360 e-CTABrainomix Limited20250—
+5K231570StrokeViewer PerfusionNico-Lab B.V.20230—
+5K230016Cercare Medical NeurosuiteCercare Medical A/S20232—
+5K213986CerebralGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+5K230294CoverScan (CoverScan v1.1)Perspectum20230—
+5K213165RapidIschemaview, Inc.20227—
+5K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+5K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K252526Rapid DeltaFuseIschemaview, Inc.20250—
+6K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+6K233582RapidIschemaview, Inc.20243—
+6K233512Rapid (6.0)Ischemaview, Inc.20241—
+7K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+7K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+7K243350Rapid Neuro3DIschemaview, Inc.20251—
+8K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—