510(k) Report

Devices descending from K042540

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+3K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+3K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+3K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+3K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+3K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+3K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+3K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+3K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+3K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+3K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+3K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+3K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+3K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+3K132274AixplorerSupersonic Imagine2013312—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+3K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+3K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+3K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K122574Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6Edan Instruments, Inc.20121—
+3K112255AixplorerSupersonic Imagine2012525—
+3K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+3K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K112022Dus-3000/Dus-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20110—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+3K110688MylabgoldEsaote2011251
+3K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+3K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+3K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+3K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+3K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+3K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+3K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+3K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+3K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+3K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd.20100—
+3K091166IMRXImris, Inc.20091—
+3K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K083882MylabfiveEsaote Europe B.V.200926—
+3K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+3K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+3K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070903MYLAB40Esaote Europe B.V.200727—
+4K260748ES-SeriesE-Scopics20260—
+4K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K250120GECHONarnar, LLC20250—
+4K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+4K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+4K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+4K232895B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20240—
+4K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+4K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+4K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+4K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+4K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+4K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+4K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+4K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+4K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+4K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+4K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+4K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+4K190913QLAB Advanced Quantification Software 13Philips Health Care20191—