510(k) Report

Devices descending from K991805

1,093 later devices reach Aspen Ultrasound with Freestyle Imaging Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K150239FibroScanEchosens201525—
+9K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+9K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+9K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+9K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+9K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+9K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+9K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+9K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+9K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+9K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+9K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+9K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+9K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+9K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+9K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+9K140808Q-StationPhilips Ultrasound, Inc.201402
+9K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+9K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+9K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+9K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+9K123806FibroscanEchosens201355—
+9K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+9K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+9K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+9K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+9K111582Logiq S8GE Healthcare20113673
+9K110943Logiq E9GE Healthcare20114722
+9K103649Voluson S6, Voluson S8GE Healthcare2011296—
+9K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+9K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+9K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+10K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+10K252332FolliscanMim Fertility20260—
+10K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K252105Ligence HeartLigence Uab20250—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K243937Accuro 3SRivanna Medical, Inc.20252—
+10K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+10K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+10K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+10K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+10K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+10K241430EchoMeasureIcardio.Ai20240—
+10K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+10K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+10K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+10K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+10K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+10K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+10K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+10K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+10K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+10K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+10K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+10K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K212100KosmosEchoNous, Inc.202101
+10K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+10K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+10K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+10K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+10K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+10K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+10K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+10K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+10K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+10K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+10K192152DC-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—
+10K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+10K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+10K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+10K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+10K182845minisonoAlpinion Medical Systems Co., Ltd.20180—