510(k) Report

Devices descending from K011457

331 later devices reach Aloka SSD-5500 with KI and a-Sma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040719Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryAloka Co., Ltd.200427—
+1K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA2003124—
+1K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd.2001207—
+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
+2K110688MylabgoldEsaote2011251
+2K093488Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemAloka Co., Ltd.20090—
+2K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+2K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+2K061961Art Lab SoftwarePie Medical200618—
+2K043196Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd.2004106—
+2K041916Aloka SSD-Alpha 5 Ultrasound SystemAloka Co. Ltd USA200412—
+2K020668Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124Aloka Co., Ltd.20020—
+3K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K140854Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd.20141—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K140639Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.201460—
+3K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+3K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd.201191—
+3K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+3K093395Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound GastrovideoscopeOlympus Medical Systems Corporation201014
+3K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+3K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+3K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+3K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+3K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+3K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+3K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+3K072285Aloka SSD-Alpha 7 Ultrasound SystemAloka Co., Ltd.20073—
+3K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+4K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+4K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+4K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+4K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+4K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+4K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+4K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+4K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+4K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+4K163505Arietta PrecisionHitachi, Ltd.20170—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+4K162583Aloka Lisendo 880Hitachi, Ltd.201602
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+4K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…Hitachi Aloka Medical America, Inc.20140—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+4K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+4K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+4K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+4K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+4K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+4K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+4K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+4K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+4K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+5K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+5K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+5K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+5K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+5K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—