510(k) Report

Devices descending from K040719

27 later devices reach Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110688MylabgoldEsaote2011251
+1K093488Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemAloka Co., Ltd.20090—
+2K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+2K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+2K140677MylabssognoEsaote, S.p.A.20140—
+2K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+2K121384MylabsognoEsaote, S.p.A.201211
+3K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+3K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+3K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+3K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K142077MylabgammaEsaote, S.p.A.201453
+3K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+7K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+7K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+8K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—