510(k) Report

Devices descending from K930265

32 later devices reach Hydrogen Spectroscopy Option-Probe #M1040HS/HT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc.20080—
+1K011604Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MriGe Medical Systems, Inc.200121—
+1K991568MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc.19996—
+1K983139Signa 1.5T Phosphorus (P) Transmit/Receive Flex CoilGE Medical Systems19990—
+1K970005Gyrex 2T-PrestigeElscint, Inc.19970—
+2K071506Echelon Spectroscopy PackageHitachi Medical Systems America, Inc.20075—
+2K0508623TP Workspace3tp, LLC2005101
+2K0313503TP Software Option3tp, LLC2003191
+3K093044Oasis Mri SystemHitachi Medical Systems America, Inc.201041
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+3K041286Dynacad V1.0Mri Devices Corp.200417—
+4K192851OASIS MRI SystemHitachi Healthcare Americas20203—
+4K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+4K173744ProFuse CADEigen20181—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+4K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K202030OASIS MRI SystemHitachi Healthcare Americas202021
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K173312ProBx SoftwareHarmonus, Inc.20180—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K211406OASIS MRI SystemHitachi Healthcare Americas20211—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K240571OASIS MRI SystemFujifilm Healthcare Corporation20240—