510(k) Report

Devices descending from K042540

882 later devices reach Philips IU22 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+4K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+4K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+4K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+4K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+4K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+4K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+4K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+4K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K163443Interson USB Ultrasound SystemInterson Corporation20173—
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161960bk2300Bk Medical Aps20165—
+4K162549Lumify Ultrasound SystemPhilips Health Care2016436
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+4K160420SpeqTSignostics Limited20161—
+4K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+4K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+4K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+4K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+4K150239FibroScanEchosens201525—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+4K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+4K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+4K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+4K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K142077MylabgammaEsaote, S.p.A.201453
+4K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+4K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+4K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+4K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+4K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+4K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+4K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+4K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+4K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+4K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+4K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+4K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+4K123806FibroscanEchosens201355—
+4K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+4K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K121513Multix FusionSiemens Medical Solution2012324
+4K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+4K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+4K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+4K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+4K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+4K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+4K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+4K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+4K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+4K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+4K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+4K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+4K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+4K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+5K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+5K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+5K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+5K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+5K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+5K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K233734Interson USB Ultrasound SystemInterson Corporation20230—