510(k) Report

Devices descending from K032576

21 later devices reach Biopsy Breast Coil, Model BBC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…Philips Medical Systems Nederland B.V.20260—
+1K232762dS Breast Coil 7ch 1.5TInvivo Corporation (Business Trade Name: Philips)20231—
+1K122646DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0TInvivo Corporation20120—
+1K041286Dynacad V1.0Mri Devices Corp.200417—
+2K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+2K173744ProFuse CADEigen20181—
+2K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+3K173312ProBx SoftwareHarmonus, Inc.20180—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K092954Cadstream Version 5Confirma, Inc.200983
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K210670BU-CADTaihao Medical, Inc.20213—
+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—