510(k) Report

Devices descending from K963262

51 later devices reach Artoscan M through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032121Modification to E-Scan XQEsaote, S.p.A.200347—
+1K020164E-Scan XQBiosound Esaote, Inc.200248—
+1K981358Artoscan SBiosound Esaote, Inc.199850—
+2K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A.200632—
+2K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A.200643—
+2K042236G-SCANEsaote, S.p.A.200445—
+2K041145Modification to E-Scan XQ Mri SystemEsaote, S.p.A.20040—
+2K990968E-SCANBiosound Esaote, Inc.199949—
+3K110238G-SCANEsaote, S.p.A.201115—
+3K080762IB Neuro, Version 1.0Imaging Biometrics, LLC20085—
+3K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A.200824—
+3K073167Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC20086—
+3K063207S-Scan Mri SystemEsaote, S.p.A.200634—
+3K052077G-Scan Cervical Spine CoilEsaote, S.p.A.20050—
+4K153039MRI Dynamic Analysis PlusEsaote, S.p.A.20167—
+4K123302IB ClinicImaging Biometrics, LLC20131—
+4K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+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—
+4K100670S-Scan, Model 9800020010Esaote, S.p.A.20100—
+4K092469O-Scan MR SystemEsaote, S.p.A.200918—
+4K091444PerfscapeOlea Medical20090—
+4K080098MRJ ExtendedParamed S.R.L.20088—
+5K211356GIQuantMotilent, Ltd.20210—
+5K183685O-ScanEsaote, S.p.A.20190—
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K161238S-scanEsaote, S.p.A.20166—
+5K151074Magnetic Reasonance Imaging SystemJiangsu Magspin Instrument Co.,Ltd20150—
+5K142421G-scan BrioEsaote, S.p.A.201591
+5K120288Orthocad Software OptionEsaote, S.p.A.20120—
+5K122006G-Scan BrioEsaote, S.p.A.201211—
+5K121650S-SCANEsaote, S.p.A.201210—
+5K121249Multiarray KitParamed S.R.L.20126—
+5K100164MR Inspire with Extended KitParamed S.R.L.20107—
+6K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A.20190—
+6K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+6K151466MrOpenParamed S.R.L.20153—
+6K151668S-scanEsaote, S.p.A.20158—
+6K133490G-Scan BrioEsaote, S.p.A.201310—
+6K131996S-SCANEsaote, S.p.A.20139—
+6K122034MRJ 3300Paramed S.R.L.20124—
+7K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+7K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+7K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+8K261331I-Genius (100019400)Esaote, S.p.A.20260—
+8K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+8K193116MRopen EVOAsg Superconductors S.P.A.20191—
+9K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+9K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—