510(k) Report

Devices descending from K980157

65 later devices reach Premier 7000 CTL Spine Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031366Premier 9000 8 Channel Phased Array CTL Spine CoilUsa Instruments, Inc.20030—
+1K031056Modification to Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc.20030—
+1K030042Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc.20032—
+1K020268Isaac 1.5 T MR SystemChi, Inc.20020—
+1K014086CTL Body / Spine Array CoilUsa Instruments, Inc.20020—
+1K013595Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc.20023—
+1K994345Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc.200051—
+1K983143Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc.19987—
+2K063207S-Scan Mri SystemEsaote, S.p.A.200634—
+2K042236G-SCANEsaote, S.p.A.200445—
+2K0421863.0T 8-Channel CTL Spine ArrayUsa Instruments, Inc.20040—
+2K0325383.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array CoilUsa Instruments, Inc.20030—
+2K0324743.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array CoilUsa Instruments, Inc.20030—
+2K031139Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc.20030—
+2K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc.20025—
+2K013541Shoulder CoilUsa Instruments, Inc.20010—
+3K110238G-SCANEsaote, S.p.A.201115—
+3K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A.200824—
+3K080098MRJ ExtendedParamed S.R.L.20088—
+3K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A.200643—
+3K052077G-Scan Cervical Spine CoilEsaote, S.p.A.20050—
+3K033753Pelvic Array CoilUsa Instruments, Inc.20034—
+4K153039MRI Dynamic Analysis PlusEsaote, S.p.A.20167—
+4K121249Multiarray KitParamed S.R.L.20126—
+4K120748Speedup Software OptionEsaote, S.p.A.20120—
+4K111803G-SCANEsaote, S.p.A.201114—
+4K110802A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A.201111—
+4K110373Temporomanibular Coil 15Esaote, S.p.A.20110—
+4K100164MR Inspire with Extended KitParamed S.R.L.20107—
+4K100670S-Scan, Model 9800020010Esaote, S.p.A.20100—
+4K092469O-Scan MR SystemEsaote, S.p.A.200918—
+4K0719661.5T Mrgfus Pelvic CoilInsightec-Txsonics, Inc.20070—
+4K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc.20062—
+4K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A.200632—
+5K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A.20190—
+5K183685O-ScanEsaote, S.p.A.20190—
+5K161238S-scanEsaote, S.p.A.20166—
+5K151074Magnetic Reasonance Imaging SystemJiangsu Magspin Instrument Co.,Ltd20150—
+5K151466MrOpenParamed S.R.L.20153—
+5K142421G-scan BrioEsaote, S.p.A.201591
+5K122034MRJ 3300Paramed S.R.L.20124—
+5K120288Orthocad Software OptionEsaote, S.p.A.20120—
+5K122006G-Scan BrioEsaote, S.p.A.201211—
+5K121650S-SCANEsaote, S.p.A.201210—
+5K083434TT1 General Purpose CoilTursiop Technologies, LLC20081—
+5K080762IB Neuro, Version 1.0Imaging Biometrics, LLC20085—
+5K073167Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC20086—
+6K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+6K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+6K151668S-scanEsaote, S.p.A.20158—
+6K133490G-Scan BrioEsaote, S.p.A.201310—
+6K131996S-SCANEsaote, S.p.A.20139—
+6K123302IB ClinicImaging Biometrics, LLC20131—
+6K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+6K113280Carotid Coil GE 1.5TTursiop Technologies, LLC20110—
+6K091444PerfscapeOlea Medical20090—
+7K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+7K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+7K211356GIQuantMotilent, Ltd.20210—
+7K193116MRopen EVOAsg Superconductors S.P.A.20191—
+7K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+8K261331I-Genius (100019400)Esaote, S.p.A.20260—
+8K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—
+8K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+9K251901Magnifico Open (100009900)Esaote, S.p.A.20260—