510(k) Report

Devices descending from K000832

5 later devices reach Sterotactic Localization Device (SLD) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041020Cadstream Version 3.1Confirma, Inc.20040—
+1K023686Aurora MR-Guided Interventional SystemAurora Imaging Technology, Inc.20030—
+1K020289Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasMachnet BV20023—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc.20070—