510(k) Report

Devices descending from K053154

29 later devices reach MYLAB15/20 3D/4D Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070903MYLAB40Esaote Europe B.V.200727—
+1K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+2K083882MylabfiveEsaote Europe B.V.200926—
+3K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+3K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K142077MylabgammaEsaote, S.p.A.201453
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+6K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+8K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+8K170841BiopSee, Mobile USMedcom GmbH20170—
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+10K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+10K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+10K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+11K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+11K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—