510(k) Report

Devices descending from K010942

12 later devices reach U04 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+2K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+2K161019Uroview FDPausch Medical GmbH201621
+2K122768GenesisDornier Medtech America, Inc.20134—
+2K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+3K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+3K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+3K180651Uroview FD IIPausch Medical GmbH20180—
+3K151485GenesisDornier Medtech America, Inc.20151—
+3K133434Genesis IIDornier Medtech America, Inc.20142—
+3K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+4K220871NautilusDornier Medtech America, Inc.20220—