510(k) Report

Devices descending from K960497

39 later devices reach Flexible Phased Array Spine Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983143Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc.19987—
+1K972340Insight 7000 Phased Array Torso CoilUsa Instruments, Inc.19970—
+1K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc.199726—
+1K964820Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15AUs Asia Instruments, Inc.19970—
+1K964753Matrix 3000 Flexible Spine CoilUs Asia Instruments, Inc.19971—
+2K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc.200322—
+2K020268Isaac 1.5 T MR SystemChi, Inc.20020—
+2K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc.20025—
+2K013592Extremity CoilUsa Instruments, Inc.20020—
+2K013541Shoulder CoilUsa Instruments, Inc.20010—
+2K994040Phased Array Knee and Foot CoilUsa Instruments, Inc.20001—
+2K990007Opart, Model MRT-600Toshiba America Mri, Inc.19990—
+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—
+4K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc.201012—
+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—
+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—