510(k) Report

Devices descending from K965013

10 later devices reach Digiscope RX-2 (9 Option) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0412133DSCOPEDirex Systems Corp.20049—
+2K052212MIGUEDirex Systems Corp.20061—
+2K053640IntegraDirex Systems Corp.20066—
+3K111947Duet MagnaDirex Systems Corp.20120—
+3K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.20082—
+3K062147Integra SLDirex Systems Corp.20063—
+3K061873VERT-XDirex Systems Corp.20060—
+3K061713MAGIS1;MAGIS2Direx Systems Corp.20060—
+4K252913Break WaveSonomotion, Inc.20261—
+5K261086Break WaveSonomotion, Inc.20260—