510(k) Report

Devices descending from K043196

106 later devices reach Aloka SSD-Alpha 10 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd.201191—
+1K093395Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound GastrovideoscopeOlympus Medical Systems Corporation201014
+1K072285Aloka SSD-Alpha 7 Ultrasound SystemAloka Co., Ltd.20073—
+1K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+2K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+2K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+2K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+2K122537Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical20132—
+2K123828Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.2013871
+2K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+3K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+3K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+3K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+3K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+3K140854Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd.20141—
+3K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+3K140639Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.201460—
+3K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+4K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+4K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+4K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+4K163505Arietta PrecisionHitachi, Ltd.20170—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K162583Aloka Lisendo 880Hitachi, Ltd.201602
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…Hitachi Aloka Medical America, Inc.20140—
+5K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+5K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+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—
+7K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+7K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+7K202422Arietta 65Hitachi Healthcare Americas20200—
+7K191233Arietta 750Hitachi Healthcare Americas201901
+7K190248Arietta 50Hitachi Healthcare Americas20191—
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+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—
+8K220295Arietta 50Fujifilm Healthcare Corporation20220—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+8K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+8K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+8K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+8K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+9K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+9K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+9K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+9K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+9K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+9K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+9K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+10K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+10K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+10K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+10K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+10K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+10K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+10K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+10K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+11K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+11K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+11K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+11K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+12K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+12K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+12K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+13K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+13K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+14K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—