510(k) Report

Devices descending from K011604

21 later devices reach Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0508623TP Workspace3tp, LLC2005101
+1K0313503TP Software Option3tp, LLC2003191
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+2K041286Dynacad V1.0Mri Devices Corp.200417—
+3K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+3K173744ProFuse CADEigen20181—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+3K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+4K173312ProBx SoftwareHarmonus, Inc.20180—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K251766TumorSight VizSimBioSys, Inc.20250—