510(k) Report

Devices descending from K002239

6 later devices reach Sigma 110/330 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061437Sigma 5000 Series, ImagicKontron Medical Systems Sas20063—
+1K053084Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas20053—
+1K050099Sigma 5000 Series Imagic Ultrasound SystemKontron Medical Systems Sas20053—
+2K081919UF-870 AG Diagnostic Ultrasound SystemFukuda Denshi Co., Ltd.20082—
+3K131973Unexef-38G Ultrasound SystemToyota Tsusho Corporation20140—
+3K110920UF-760AGFukuda Denshi Co., Ltd.20111—