510(k) Report

Devices descending from K002470

1,238 later devices reach M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.20021,069—
+1K022303Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound TransducerPhilips Ultrasound, Inc.20021,155—
+2K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+2K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+2K100363Ultra Dci Model 5000Ultrasound Medical Devices, Inc.20100—
+2K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+2K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+2K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc.20048824
+2K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+2K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+2K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20031,003—
+2K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20039551
+3K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+3K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+3K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K120525Qlab Quantification SoftwarePhilips Healthcare Group201292—
+3K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+3K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+3K103761Visualize: VascularThe Medipattern Corporation20110—
+3K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+3K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+3K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+3K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070903MYLAB40Esaote Europe B.V.200727—
+3K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+3K070077Ultrasound Scanner Profocus, Model 2202B-K Medical Aps20070—
+3K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+3K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+3K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+3K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006191—
+3K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+3K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+3K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+3K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A.200564—
+3K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+3K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+3K042044Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20044291
+3K041581Compacs, Version 1.0Intelligent Images Srl20041—
+3K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+3K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+3K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+4K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+4K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+4K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+4K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+4K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+4K170069AmCAD-UVAmcad Biomed Corporation20170—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K161382LVivo Software ApplicationDiacardio, Ltd.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—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+4K142100AixplorerSupersonic Imagine201463—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+4K140153Ventripoint Medical SystemVentripoint, Inc.20142—
+4K140254EZONO 4000Ezono AG201413—