510(k) Report

Devices descending from K001334

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092469O-Scan MR SystemEsaote, S.p.A.200918—
+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—
+1K042236G-SCANEsaote, S.p.A.200445—
+1K032232Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc.200362
+1K030918Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd.20038—
+1K022390Hitachi AltaireHitachi Medical Systems America, Inc.200205
+2K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+2K233629APERTO Lucent MRI SystemFUJIFILM Healthcare Americas Corporation20242—
+2K183685O-ScanEsaote, S.p.A.20190—
+2K151074Magnetic Reasonance Imaging SystemJiangsu Magspin Instrument Co.,Ltd20150—
+2K120748Speedup Software OptionEsaote, S.p.A.20120—
+2K110238G-SCANEsaote, S.p.A.201115—
+2K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A.200824—
+2K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd.20073—
+2K063207S-Scan Mri SystemEsaote, S.p.A.200634—
+2K061132Modification to Superopen 0.35T, Model NSM-P035Neusoft Medical Systems Co., Ltd.20060—
+2K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A.200643—
+2K052077G-Scan Cervical Spine CoilEsaote, S.p.A.20050—
+2K050307Airis Elite Rapid Body CoilHitachi Medical Systems America, Inc.20050—
+2K033315Superopen 0.23T, Model Nam-P023ANeusoft Digital Medical Systems Co., Ltd.20032—
+3K253862APERTO Lucent MRI SystemFujifilm Corporation20261—
+3K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+3K153039MRI Dynamic Analysis PlusEsaote, S.p.A.20167—
+3K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd.20140—
+3K111803G-SCANEsaote, S.p.A.201114—
+3K110802A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A.201111—
+3K110373Temporomanibular Coil 15Esaote, S.p.A.20110—
+3K100670S-Scan, Model 9800020010Esaote, S.p.A.20100—
+3K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd.20090—
+3K082485Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd.20080—
+3K080098MRJ ExtendedParamed S.R.L.20088—
+3K062860Modification to Superopen 0.23T, Model Nam-P023ANeusoft Medical Systems Co., Ltd.20061—
+3K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A.200632—
+4K261283APERTO Lucent MRI SystemFujifilm Corporation20260—
+4K161238S-scanEsaote, S.p.A.20166—
+4K142421G-scan BrioEsaote, S.p.A.201591
+4K120288Orthocad Software OptionEsaote, S.p.A.20120—
+4K122006G-Scan BrioEsaote, S.p.A.201211—
+4K121650S-SCANEsaote, S.p.A.201210—
+4K121249Multiarray KitParamed S.R.L.20126—
+4K100164MR Inspire with Extended KitParamed S.R.L.20107—
+4K080762IB Neuro, Version 1.0Imaging Biometrics, LLC20085—
+4K073167Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC20086—
+5K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A.20190—
+5K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+5K151466MrOpenParamed S.R.L.20153—
+5K151668S-scanEsaote, S.p.A.20158—
+5K133490G-Scan BrioEsaote, S.p.A.201310—
+5K131996S-SCANEsaote, S.p.A.20139—
+5K123302IB ClinicImaging Biometrics, LLC20131—
+5K122034MRJ 3300Paramed S.R.L.20124—
+5K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+5K091444PerfscapeOlea Medical20090—
+6K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+6K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+6K211356GIQuantMotilent, Ltd.20210—
+6K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+6K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+7K261331I-Genius (100019400)Esaote, S.p.A.20260—
+7K193116MRopen EVOAsg Superconductors S.P.A.20191—
+8K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—