510(k) Report

Devices descending from K891689

901 later devices reach Mipron/Umipron through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K2013523D Auto LAAPhilips Health Care20200—
+10K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+10K200356Medo AriaMedo.Ai20203—
+10K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+10K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+10K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+10K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+10K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+10K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+10K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+10K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+10K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+10K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+10K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+10K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+10K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+10K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+10K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+10K163119NaviSuite SSI EditionMedcom GmbH20171—
+10K163690DC-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—
+10K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+10K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+10K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+10K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+10K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+10K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+10K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+10K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+10K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+10K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+10K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+10K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+10K1619555D ViewerSamsung Medison Co., Ltd.20163—
+10K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+10K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+10K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+10K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+10K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+10K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+10K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+10K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+10K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+10K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+10K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+10K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+10K150239FibroScanEchosens201525—
+10K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+10K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+10K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+10K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+10K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+10K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+10K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+10K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+10K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+10K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+10K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+10K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+10K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+10K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+10K142077MylabgammaEsaote, S.p.A.201453
+10K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+10K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+10K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+10K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+10K140808Q-StationPhilips Ultrasound, Inc.201402
+10K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+10K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+10K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+10K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+10K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+10K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+10K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+10K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+10K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+10K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+10K123806FibroscanEchosens201355—
+10K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+10K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+10K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+10K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+10K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+10K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+10K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+10K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+10K111582Logiq S8GE Healthcare20113673
+10K110943Logiq E9GE Healthcare20114722
+10K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+10K103649Voluson S6, Voluson S8GE Healthcare2011296—
+10K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+10K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+10K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+11K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+11K252332FolliscanMim Fertility20260—