510(k) Report

Devices descending from K041213

9 later devices reach 3DSCOPE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052212MIGUEDirex Systems Corp.20061—
+1K053640IntegraDirex Systems Corp.20066—
+2K111947Duet MagnaDirex Systems Corp.20120—
+2K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.20082—
+2K062147Integra SLDirex Systems Corp.20063—
+2K061873VERT-XDirex Systems Corp.20060—
+2K061713MAGIS1;MAGIS2Direx Systems Corp.20060—
+3K252913Break WaveSonomotion, Inc.20261—
+4K261086Break WaveSonomotion, Inc.20260—