510(k) Report

Devices descending from K980468

85 later devices reach AU5 Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092182Voyager Compact Imaging SystemArdent Sound, Inc.20090—
+1K060800Seeker/Spark Ultrasound SystemArdent Sound, Inc.20062—
+1K050551Voyager Personal Imaging DeviceArdent Sound, Inc.20058—
+1K013142DiasusDynamic Imaging, Ltd.200110—
+1K990360AU6Biosound Esaote, Inc.199983—
+2K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+2K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+2K102253Echo BlasterTelemed20111—
+2K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A.200564—
+2K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Biosound Esaote, Inc.200271—
+3K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+3K171594AccuroRivanna Medical, LLC20173—
+3K161968MicrUsTelemed20160—
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K142077MylabgammaEsaote, S.p.A.201453
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+3K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+3K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+3K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+3K052805MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A.200560—
+3K051308Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A.200564—
+3K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A.2004674
+3K023255Technos MP, Model AU6Biosound Esaote, Inc.200366—
+4K243937Accuro 3SRivanna Medical, Inc.20252—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110688MylabgoldEsaote2011251
+4K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K083882MylabfiveEsaote Europe B.V.200926—
+4K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+4K070903MYLAB40Esaote Europe B.V.200727—
+4K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A.2005661
+5K253452Accuro 3SRivanna Medical, Inc.20260—
+5K254021Accuro XVRivanna Medical, Inc.20260—
+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—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K161999AixplorerSupersonic Imagine201620—
+5K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+5K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K200655FibroScan® 630Echosens20200—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+10K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+13K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+14K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+15K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+15K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—