510(k) Report

Devices descending from K964531

45 later devices reach Profile 70000 Quadrature Volume Neck Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022582Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc.20026—
+1K020268Isaac 1.5 T MR SystemChi, Inc.20020—
+1K983143Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc.19987—
+1K981959Outlook Large Phased Array Neck CoilPhilips Medical Systems (Cleveland), Inc.19980—
+1K972205Alpha 7000 Quadrature Wrist CoilUsa Instruments, Inc.199728—
+2K072935Speeder 1.5T Wrist Array CoilQuality Electrodynamics20072—
+2K041487QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc.20045—
+2K031143Alpha 5000 Wrist CoilUsa Instruments, Inc.20033—
+2K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc.200322—
+2K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc.20025—
+2K013541Shoulder CoilUsa Instruments, Inc.20010—
+3K0831601.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics200841
+3K083014Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C20081—
+3K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics2008218
+3K033753Pelvic Array CoilUsa Instruments, Inc.20034—
+4K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC20160—
+4K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC20160—
+4K15033118ch T/R Knee CoilQuality Electrodynamics, LLC20155—
+4K142802Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC20141—
+4K122638Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics20120—
+4K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan20120—
+4K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc.201012—
+4K093667Shoulder Speeder CoilQuality Electrodynamics20100—
+4K0719661.5T Mrgfus Pelvic CoilInsightec-Txsonics, Inc.20070—
+4K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc.20062—
+5K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC20161—
+5K16202916ch T/R Knee CoilQuality Electrodynamics, LLC20160—
+5K15175316 ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC20151—
+5K151829Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC20150—
+5K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.201311—
+5K083434TT1 General Purpose CoilTursiop Technologies, LLC20081—
+6K17346916ch T/R Hand Wrist CoilQuality Electrodynamics, LLC20180—
+6K161795Magnetom EssenzaSiemens Medical Solutions USA, Inc.20160—
+6K16119316ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC20160—
+6K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20159—
+6K113280Carotid Coil GE 1.5TTursiop Technologies, LLC20110—
+7K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc.20177—
+7K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.20177—
+8K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+9K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+9K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+10K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.202231
+11K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+12K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+13K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20260—