510(k) Report

Devices descending from K040227

908 later devices reach Qlab Quantification Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+4K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20171—
+4K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+4K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+4K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+4K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+4K161999AixplorerSupersonic Imagine201620—
+4K163020Xperius Ultrasound SystemPhilips Health Care201611
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+4K1619555D ViewerSamsung Medison Co., Ltd.20163—
+4K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+4K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+4K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+4K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+4K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+4K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+4K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+4K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+4K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+4K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+4K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+4K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+4K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+4K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+4K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+4K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+4K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+4K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+4K132274AixplorerSupersonic Imagine2013312—
+4K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+4K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+4K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+4K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K122574Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6Edan Instruments, Inc.20121—
+4K112255AixplorerSupersonic Imagine2012525—
+4K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+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—
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+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—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K110688MylabgoldEsaote2011251
+4K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+4K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+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—
+4K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+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—
+4K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+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—
+4K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd.20100—
+4K091166IMRXImris, Inc.20091—
+4K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K083882MylabfiveEsaote Europe B.V.200926—
+4K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+4K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+4K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+4K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+4K070903MYLAB40Esaote Europe B.V.200727—
+5K260748ES-SeriesE-Scopics20260—
+5K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+5K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K250120GECHONarnar, LLC20250—
+5K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+5K243614Sonio SuspectSonio20251—
+5K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—