510(k) Report

Devices descending from K984224

33 later devices reach Perfusion Package for Magnetom Vision and Symphony Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080762IB Neuro, Version 1.0Imaging Biometrics, LLC20085—
+1K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A.200632—
+2K123302IB ClinicImaging Biometrics, LLC20131—
+2K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+2K091444PerfscapeOlea Medical20090—
+2K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A.200824—
+2K073167Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC20086—
+3K211356GIQuantMotilent, Ltd.20210—
+3K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+3K153039MRI Dynamic Analysis PlusEsaote, S.p.A.20167—
+3K120748Speedup Software OptionEsaote, S.p.A.20120—
+3K110802A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A.201111—
+3K110373Temporomanibular Coil 15Esaote, S.p.A.20110—
+3K110238G-SCANEsaote, S.p.A.201115—
+3K100670S-Scan, Model 9800020010Esaote, S.p.A.20100—
+3K092469O-Scan MR SystemEsaote, S.p.A.200918—
+4K183685O-ScanEsaote, S.p.A.20190—
+4K161238S-scanEsaote, S.p.A.20166—
+4K151074Magnetic Reasonance Imaging SystemJiangsu Magspin Instrument Co.,Ltd20150—
+4K121650S-SCANEsaote, S.p.A.201210—
+4K111803G-SCANEsaote, S.p.A.201114—
+5K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+5K142421G-scan BrioEsaote, S.p.A.201591
+5K131996S-SCANEsaote, S.p.A.20139—
+5K120288Orthocad Software OptionEsaote, S.p.A.20120—
+5K122006G-Scan BrioEsaote, S.p.A.201211—
+6K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+6K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+6K151668S-scanEsaote, S.p.A.20158—
+6K133490G-Scan BrioEsaote, S.p.A.201310—
+7K261331I-Genius (100019400)Esaote, S.p.A.20260—
+7K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+8K251901Magnifico Open (100009900)Esaote, S.p.A.20260—