510(k) Report

Devices descending from K946179

931 later devices reach Siemens Sonoline 4XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+8K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+8K163119NaviSuite SSI EditionMedcom GmbH20171—
+8K163690DC-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—
+8K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+8K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+8K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+8K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+8K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+8K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+8K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+8K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+8K1619555D ViewerSamsung Medison Co., Ltd.20163—
+8K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+8K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+8K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+8K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+8K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+8K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+8K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+8K150239FibroScanEchosens201525—
+8K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+8K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+8K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+8K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+8K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+8K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+8K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+8K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+8K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+8K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+8K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+8K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+8K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+8K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+8K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+8K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+8K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+8K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+8K142077MylabgammaEsaote, S.p.A.201453
+8K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+8K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+8K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+8K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+8K140808Q-StationPhilips Ultrasound, Inc.201402
+8K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+8K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+8K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+8K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+8K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+8K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+8K131158CorviewMarrek, Inc.20130—
+8K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+8K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+8K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+8K123806FibroscanEchosens201355—
+8K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+8K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+8K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+8K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+8K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+8K111582Logiq S8GE Healthcare20113673
+8K110943Logiq E9GE Healthcare20114722
+8K103649Voluson S6, Voluson S8GE Healthcare2011296—
+8K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+8K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+8K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+9K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+9K252105Ligence HeartLigence Uab20250—
+9K250670EchoConfidence (USA)Mycardium AI Limited20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+9K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+9K241430EchoMeasureIcardio.Ai20240—
+9K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+9K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+9K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+9K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+9K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—