510(k) Report

Devices descending from K974212

32 later devices reach Airis II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092899Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4Ningbo Xingaoyi Magnetism Co., Ltd.20090—
+1K090873I Open 0.5TBeijing Wandong Medical Equipment Co., Ltd.20090—
+1K090433I_Open 0.4TBeijing Wandong Medical Equipment Co., Ltd.20090—
+1K090080Cirrus OpenMri-Tech Sp. Zo.O.20090—
+1K032232Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc.200362
+1K030918Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd.20038—
+1K994378Airis IIHitachi Medical Systems America, Inc.20000—
+1K990153Virgo Mri SystemMillennium Technology Services19990—
+1K984280Airis II Magnetic Resonance Diagnostic Device,Interventional MR PackageHitachi Medical Systems America, Inc.19991—
+1K984278Magnetic Resonance Diagnostic Device, Airis IIHitachi Medical Systems America, Inc.19988—
+2K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+2K233629APERTO Lucent MRI SystemFUJIFILM Healthcare Americas Corporation20242—
+2K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd.20073—
+2K061132Modification to Superopen 0.35T, Model NSM-P035Neusoft Medical Systems Co., Ltd.20060—
+2K053309Altaire Interventional MR PackageHitachi Medical Systems America, Inc.20060—
+2K050307Airis Elite Rapid Body CoilHitachi Medical Systems America, Inc.20050—
+2K033315Superopen 0.23T, Model Nam-P023ANeusoft Digital Medical Systems Co., Ltd.20032—
+2K992650Airis, Airis IIHitachi Medical Systems America, Inc.19997—
+3K253862APERTO Lucent MRI SystemFujifilm Corporation20261—
+3K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+3K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd.20140—
+3K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd.20090—
+3K082485Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd.20080—
+3K062860Modification to Superopen 0.23T, Model Nam-P023ANeusoft Medical Systems Co., Ltd.20061—
+3K062556Echelon Shoulder CoilHitachi Medical Systems America, Inc.20060—
+3K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc.20025—
+4K261283APERTO Lucent MRI SystemFujifilm Corporation20260—
+4K033753Pelvic Array CoilUsa Instruments, Inc.20034—
+5K0719661.5T Mrgfus Pelvic CoilInsightec-Txsonics, Inc.20070—
+5K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc.20062—
+6K083434TT1 General Purpose CoilTursiop Technologies, LLC20081—
+7K113280Carotid Coil GE 1.5TTursiop Technologies, LLC20110—