510(k) Report

Devices descending from K132095

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161601DynamikaImage Analysis Limited20170—
+1K152602Olea Sphere V3.0Olea Medical201617—
+1K153103CARESTREAM Vue PACSCarestream Health, Inc.201601
+2K243681Neuro Insight V1.0Olea Medical S.A.S.20250—
+2K223091CT Perfusion V1.0Olea Medical20230—
+2K223532Olea S.I.A. Neurovascular V1.0Olea Medical20231—
+2K230552MR DWI/FLAIR Measurement V1.0Olea Medical20230—
+2K211059CereFlow™ V1.2Translational Mri, LLC20231—
+2K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical20230—
+2K212565CoverScan v1Perspectum, Ltd.20221—
+2K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L.20211—
+2K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20191—
+2K173467Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V.20170—
+2K170580Carestream Vue PACSCarestream Health, Inc.20171—
+3K253794Prostate CoreLucida Medical, Ltd.20260—
+3K253421Perfusion Measurement Platform v1Quantified Imaging Limited20260—
+3K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+3K230294CoverScan (CoverScan v1.1)Perspectum20230—
+3K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+3K201948AcroDTI VisualizerAcroviz, Inc.20200—