510(k) Report

Devices descending from K081386

53 later devices reach Model 6150 (MYLAB70) and Model 6100 (MYLAB90) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+1K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+1K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+1K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+1K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+2K161999AixplorerSupersonic Imagine201620—
+2K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+2K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+2K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+2K140677MylabssognoEsaote, S.p.A.20140—
+2K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+2K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+2K121384MylabsognoEsaote, S.p.A.201211
+2K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+2K110688MylabgoldEsaote2011251
+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—
+3K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K163119NaviSuite SSI EditionMedcom GmbH20171—
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+3K142077MylabgammaEsaote, S.p.A.201453
+3K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K170841BiopSee, Mobile USMedcom GmbH20170—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K200655FibroScan® 630Echosens20200—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+6K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+6K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+7K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+7K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+7K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+7K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+7K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+8K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+8K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+9K242223SuperSonic HepaVuSupersonic Imagine20240—
+9K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+12K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+12K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—