510(k) Report

Devices descending from K110151

34 later devices reach Achieva R4 1.5T and Achieva R4 3.0T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsPhilips Medical Systems Nederland B.V.201902
+1K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V.2017197
+1K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.201612—
+1K153324Ingenia 1.5T and Ingenia 1.5T S R5.2Philips Medical Systems Nederlands B.V.201603
+1K151212Ziostation2Qi Imaging, LLC20152—
+1K143606MultiBand SENSEPhilips Medical Systems Nethrlands BV201513—
+1K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+1K123492DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)Philips Medical Systems20121—
+2K254190dS 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—
+2K210415QSM software, QSMetricMedimagemetric, LLC20210—
+2K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.202011152
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K173079Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V.20181511
+2K173451Ingenia Elition S and Ingenia Elition XPhilips Medical Systems Nederland B.V.2018014
+2K173356Ingenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V.2018013
+2K173224Spin-SwiSpintech, Inc.20183—
+2K1729203D APTPhilips Medical Systems Nederland B.V.20180—
+3K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia…Philips Medical Systems Nederland B.V.2025019
+3K232030Ingenia Elition R5.7.1 SP4 MR SystemsPhilips Medical Systems Nederland B.V.202301
+3K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+3K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.2022539
+3K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V.2022545
+3K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+3K212673MR 5300Philips Medical Systems Nederland B.V.2021617
+3K210843STAGESpintech, Inc.20211—
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.20191325
+3K181479Ingenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V.201808
+4K230972Ingenia Elition and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.2023019
+4K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.2023217
+4K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V.202245
+4K223079StageSpintech, Inc.20220—
+5K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR…Philips Medical Systems Nederland B.V.2025115
+6K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…Philips Medical Systems Nederland B.V.20260—