510(k) Report

Devices descending from K050099

3 later devices reach Sigma 5000 Series Imagic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081919UF-870 AG Diagnostic Ultrasound SystemFukuda Denshi Co., Ltd.20082—
+2K131973Unexef-38G Ultrasound SystemToyota Tsusho Corporation20140—
+2K110920UF-760AGFukuda Denshi Co., Ltd.20111—