510(k) Report

Devices descending from K071550

4 later devices reach Pre-Waxed Needles with Gold Fiduciary Markers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical20113—
+2K131689Mri MarkerC4 Imaging, LLC20131—
+2K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+3K171487Sirius MRI Marker NSC4 Imaging, LLC20170—