510(k) Report

Devices descending from K031815

67 later devices reach Intera-Sensation Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043147Achieva FamilyPhilips Medical Systems North America Co.200565Class I
+1K041602Panorama 1.0TPhilips Medical Systems North America, Inc.200458Class I
+2K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilRapid Biomedical GmbH20180—
+2K120748Speedup Software OptionEsaote, S.p.A.20120—
+2K110151Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care20113420
+2K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems200753Class I
+2K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V.200557Class I
+2K052013Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V.20054Class I
+3K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsPhilips Medical Systems Nederland B.V.201902
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K162931Ingenia 1.5T CX and Ingenia 3.0T CX R5.3Philips Medical Systems Nederland B.V.2017121
+3K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V.2017197
+3K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.201612—
+3K153324Ingenia 1.5T and Ingenia 1.5T S R5.2Philips Medical Systems Nederlands B.V.201603
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K143606MultiBand SENSEPhilips Medical Systems Nethrlands BV201513—
+3K131896Supervan 1.5T Magnetic Resonance Imaging SystemSuzhou Anke Medical System Co., Ltd.20140—
+3K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+3K123492DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)Philips Medical Systems20121—
+3K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland)201104
+3K102344Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR SystemsPhilips Medical Systems Nederland B.V.20101—
+3K100836Clearpoint SystemSurgivision, Inc.201012—
+3K081262DC NeuroInvivo Corporation20082—
+3K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc.200823
+4K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TPhilips Medical Systems Nederland B.V.20260—
+4K210415QSM software, QSMetricMedimagemetric, LLC20210—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.202011152
+4K173507Prodiva 1.5T CX and Prodiva 1.5T CS R5.4Philips Healthcare (Suzhou) Co., Ltd.20180—
+4K173079Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V.20181511
+4K173451Ingenia Elition S and Ingenia Elition XPhilips Medical Systems Nederland B.V.2018014
+4K173356Ingenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V.2018013
+4K173224Spin-SwiSpintech, Inc.20183—
+4K1729203D APTPhilips Medical Systems Nederland B.V.20180—
+4K143128mDIXON XDPhilips Medical Systems Nederlands B.V.20150—
+4K113701Visia NeuroMeVis Medical Solutions AG20121—
+4K111073Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc.201111—
+4K1032381.5T Optima MR430SGe Medical Systems, LLC201112
+5K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia…Philips Medical Systems Nederland B.V.2025019
+5K232030Ingenia Elition R5.7.1 SP4 MR SystemsPhilips Medical Systems Nederland B.V.202301
+5K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+5K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.2022539
+5K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V.2022545
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K212673MR 5300Philips Medical Systems Nederland B.V.2021617
+5K210843STAGESpintech, Inc.20211—
+5K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.20191325
+5K181479Ingenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V.201808
+5K142505ClearPoint SystemMri Interventions, Inc.201510—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K123068Optima MR 430SGe Medical Systems, LLC201202
+6K230972Ingenia Elition and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.2023019
+6K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.2023217
+6K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V.202245
+6K223079StageSpintech, Inc.20220—
+6K160434ClearPoint SystemMri Interventions, Inc.20169—
+7K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR…Philips Medical Systems Nederland B.V.2025115
+7K171257ClearPoint SystemMri Interventions, Inc.20178—
+8K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…Philips Medical Systems Nederland B.V.20260—
+8K181195ClearPoint SystemMri Interventions, Inc.20187—
+9K222519ClearPoint SystemClearPoint Neuro, Inc.20222—
+9K200079ClearPoint System and AccessoriesMri Interventions, Inc.20203—
+10K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—
+10K233243ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc.20231—
+10K202575ClearPoint Array SystemClearPoint Neuro, Inc.20212—
+11K232102ClearPoint Array System (Version 1.2)ClearPoint Neuro, Inc.20230—
+11K214040ClearPoint Array System (version 1.1)ClearPoint Neuro, Inc.20221—