Devices descending from K020353
1,026 later devices reach Omnia X/XS Ultrasound System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +9 | K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | 2024 | 0 | — |
| +9 | K241430 | EchoMeasure | Icardio.Ai | 2024 | 0 | — |
| +9 | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | 0 | 2 |
| +9 | K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound… | Leltek, Inc. | 2024 | 3 | — |
| +9 | K233697 | SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | 2024 | 1 | — |
| +9 | K240684 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | 0 | — |
| +9 | K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024 | 0 | — |
| +9 | K240053 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | 2 | 1 |
| +9 | K240206 | Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | 2 | — |
| +9 | K234106 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | 2 | 1 |
| +9 | K240111 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | 2 | — |
| +9 | K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | 0 | — |
| +9 | K233676 | Us2.v2 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2024 | 0 | — |
| +9 | K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Guangdong Youkey Medical Co., Ltd. | 2024 | 0 | — |
| +9 | K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | 2024 | 1 | — |
| +9 | K231509 | Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. | 2023 | 0 | — |
| +9 | K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2023 | 0 | — |
| +9 | K223322 | Argus Cognitive ReVISION Software | Argus Cognitive, Inc. | 2023 | 1 | — |
| +9 | K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023 | 1 | — |
| +9 | K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 3 | — |
| +9 | K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023 | 3 | — |
| +9 | K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 5 | — |
| +9 | K222406 | Clarius AI | Clarius Mobile Health Corp. | 2023 | 3 | — |
| +9 | K222754 | ViewMate Multi Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022 | 1 | — |
| +9 | K222198 | Exo Iris (El2001) | Exo Imaging, Inc. | 2022 | 0 | — |
| +9 | K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC… | Supersonic Imagine | 2022 | 1 | — |
| +9 | K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2022 | 0 | — |
| +9 | K213862 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2022 | 3 | — |
| +9 | K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 1 | — |
| +9 | K213523 | X-CUBE i8, X-CUBE i9 | Alpinion Medical Systems Co., Ltd. | 2022 | 0 | — |
| +9 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | 2022 | 6 | 1 |
| +9 | K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2022 | 2 | — |
| +9 | K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | 6 | — |
| +9 | K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | 7 | — |
| +9 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | 2021 | 17 | — |
| +9 | K211656 | 3D Echo v1.1 | Jointvue, LLC | 2021 | 0 | — |
| +9 | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | Echosens | 2021 | 9 | — |
| +9 | K210053 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2021 | 11 | — |
| +9 | K203114 | Logiq P10, Logiq P9, Logiq P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021 | 1 | — |
| +9 | K202556 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | 0 | — |
| +9 | K202364 | Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 | Canon Medical Systems Corporation | 2020 | 1 | — |
| +9 | K202546 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2020 | 2 | — |
| +9 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 3 | — |
| +9 | K201693 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 1 | — |
| +9 | K201632 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2020 | 10 | — |
| +9 | K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 4 | 2 |
| +9 | K200449 | X-Cube 90 | Alpinion Medical Systems Co., Ltd. | 2020 | 4 | — |
| +9 | K200450 | X-Cube 70 | Alpinion Medical Systems Co., Ltd. | 2020 | 4 | — |
| +9 | K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020 | 12 | — |
| +9 | K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound… | Edan Instruments, Inc. | 2020 | 1 | — |
| +9 | K200699 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | 0 | — |
| +9 | K200644 | ACUSON Freestyle Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 7 | — |
| +9 | K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | 8 | — |
| +9 | K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020 | 24 | 3 |
| +9 | K192903 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | 21 | — |
| +9 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | 41 | — |
| +9 | K192505 | HS50/HS60 Diagnostics Ultrasound System | Samsung Medison Co., Ltd. | 2019 | 10 | — |
| +9 | K192319 | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | 20 | — |
| +9 | K192791 | Diagnostic Ultrasound System | Edan Instruments, Inc. | 2019 | 1 | — |
| +9 | K191171 | EchoGo Core | Ultromics, Ltd. | 2019 | 3 | — |
| +9 | K192254 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2019 | 0 | — |
| +9 | K190913 | QLAB Advanced Quantification Software 13 | Philips Health Care | 2019 | 1 | — |
| +9 | K191115 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | 23 | — |
| +9 | K190444 | HERA I10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | 0 | — |
| +9 | K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2019 | 0 | — |
| +9 | K181985 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2018 | 17 | 1 |
| +9 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7… | Philips Ultrasound, Inc. | 2018 | 19 | 23 |
| +9 | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 13 | — |
| +9 | K182529 | Xperius Ultrasound System | Philips Ultrasound, Inc. | 2018 | 0 | — |
| +9 | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | GE Healthcare | 2018 | 2 | 1 |
| +9 | K173739 | Aloka Arietta 850 | Hitachi Healthcare Americas Corporation | 2018 | 7 | 2 |
| +9 | K173555 | Logiq E10 | GE Healthcare | 2017 | 38 | 2 |
| +9 | K172056 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2017 | 2 | — |
| +9 | K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | 35 | — |
| +9 | K171766 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017 | 20 | — |
| +9 | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017 | 48 | 1 |
| +9 | K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 11 | — |
| +9 | K160162 | Voluson P6, Voluson P8 | GE Healthcare | 2016 | 13 | — |
| +9 | K160258 | X5 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | 2 | — |
| +9 | K160524 | FibroScan 530 Compact | Echosens | 2016 | 41 | — |
| +9 | K152854 | S50 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | 16 | — |
| +9 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | 187 | — |
| +9 | K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014 | 49 | — |
| +9 | K133277 | XARIO 100 | Toshibamedical Systems Corporation | 2014 | 2 | — |
| +10 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound… | Philips Ultrasound, LLC | 2026 | 0 | — |
| +10 | K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026 | 0 | — |
| +10 | K251417 | ReVISION 2 | Argus Cognitive, Inc. | 2026 | 0 | — |
| +10 | K261288 | Handheld Ultrasound Scanner | Imgfax CO., LTD. | 2026 | 0 | — |
| +10 | K260192 | DIANA | ROPCA ApS | 2026 | 0 | — |
| +10 | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026 | 0 | — |
| +10 | K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026 | 0 | — |
| +10 | K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp… | CHISON Medical Technologies Co., Ltd. | 2026 | 0 | — |
| +10 | K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026 | 0 | — |
| +10 | K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2026 | 0 | — |
| +10 | K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | 2026 | 0 | — |
| +10 | K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | 2026 | 0 | — |
| +10 | K252235 | PVAD IQ Software | Ultrasight, Ltd. | 2025 | 0 | — |
| +10 | K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2025 | 0 | — |
| +10 | K251250 | ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | — |
| +10 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025 | 1 | — |