510(k) Report

Devices descending from K935009

1,062 later devices reach Pegasus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+10K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+10K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+10K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+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—
+10K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+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—
+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
+10K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+10K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+10K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+10K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+10K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+10K123806FibroscanEchosens201355—
+10K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+10K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+10K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+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—
+10K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+10K111582Logiq S8GE Healthcare20113673
+10K110943Logiq E9GE Healthcare20114722
+10K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+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—
+10K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, 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—
+11K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+11K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+11K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+11K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+11K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+11K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+11K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+11K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+11K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+11K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+11K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K2301796440 MyLabX90Esaote, S.p.A.202341
+11K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+11K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+11K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+11K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+11K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+11K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+11K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K211527Exo IrisExo Imaging, Inc.20211—
+11K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+11K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+11K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+11K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+11K200603AAA ModelPhilips Ultrasound, Inc.20200—
+11K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+11K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+11K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+11K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+11K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+11K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—