510(k) Report

Devices descending from K954022

343 later devices reach Aloka Omniview Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd.1999342—
+2K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117—
+2K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006191—
+2K040719Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryAloka Co., Ltd.200427—
+2K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA2003124—
+2K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd.2001207—
+3K122537Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical20132—
+3K123828Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.2013871
+3K110688MylabgoldEsaote2011251
+3K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20101—
+3K093488Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemAloka Co., Ltd.20090—
+3K091680Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.200925—
+3K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+3K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+3K081873Emp-2100 Full Digital Ultrasound Diagnostic DeviceShenzhen Emperor Electronic Technology Co., Ltd.20083—
+3K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+3K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+3K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+3K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+3K061961Art Lab SoftwarePie Medical200618—
+3K043196Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd.2004106—
+3K041916Aloka SSD-Alpha 5 Ultrasound SystemAloka Co. Ltd USA200412—
+3K020668Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124Aloka Co., Ltd.20020—
+4K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+4K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20171—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K140854Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd.20141—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K140639Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.201460—
+4K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+4K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+4K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K122574Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6Edan Instruments, Inc.20121—
+4K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+4K121384MylabsognoEsaote, S.p.A.201211
+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—
+4K112022Dus-3000/Dus-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20110—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+4K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd.201191—
+4K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+4K093395Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound GastrovideoscopeOlympus Medical Systems Corporation201014
+4K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+4K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd.20100—
+4K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+4K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+4K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+4K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+4K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+4K072285Aloka SSD-Alpha 7 Ultrasound SystemAloka Co., Ltd.20073—
+4K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+5K232895B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20240—
+5K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+5K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+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—
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+5K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+5K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+5K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+5K163505Arietta PrecisionHitachi, Ltd.20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+5K162583Aloka Lisendo 880Hitachi, Ltd.201602
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…Hitachi Aloka Medical America, Inc.20140—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+5K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+5K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+5K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+5K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+5K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+5K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+5K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+5K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+5K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+5K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+5K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—