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 |
|---|---|---|---|---|---|---|
| +10 | K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | — |
| +10 | K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp. | 2025 | 0 | — |
| +10 | K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)… | Leltek, Inc. | 2025 | 1 | — |
| +10 | K250228 | eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R… | Esonic Technology (Wuhan) Co., Ltd. | 2025 | 0 | — |
| +10 | K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8… | Edan Instruments, Inc. | 2025 | 0 | — |
| +10 | K242359 | Strain AI (SAI001) | Exo, Inc. | 2024 | 0 | — |
| +10 | K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | 1 | — |
| +10 | K242223 | SuperSonic HepaVu | Supersonic Imagine | 2024 | 0 | — |
| +10 | K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | 0 | — |
| +10 | K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | 1 | — |
| +10 | K233841 | HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2024 | 0 | — |
| +10 | K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound… | Contec Medical Systems Co.,Ltd | 2024 | 0 | — |
| +10 | K232331 | InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation | 2024 | 0 | — |
| +10 | K233439 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. | 2024 | 0 | — |
| +10 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2024 | 16 | 1 |
| +10 | K232501 | AI Platform (AIP001) | Exo, Inc. | 2023 | 1 | — |
| +10 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 4 | — |
| +10 | K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 1 | 2 |
| +10 | K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Canon Medical Systems Corporation | 2023 | 5 | — |
| +10 | K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023 | 0 | — |
| +10 | K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | Echosens | 2023 | 1 | — |
| +10 | K222970 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2023 | 6 | — |
| +10 | K221496 | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 0 | — |
| +10 | K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | — |
| +10 | K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500… | Philips Ultrasound, LLC | 2022 | 1 | 2 |
| +10 | K212376 | Caas Qardia | Pie Medical Imaging BV | 2022 | 0 | — |
| +10 | K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | 2022 | 0 | 1 |
| +10 | K214039 | Logiq P10, Logiq P9, Logiq P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | 0 | 3 |
| +10 | K220051 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | — |
| +10 | K212012 | Follicle Clarity | Cycle Clarity | 2022 | 1 | — |
| +10 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | GE Healthcare | 2022 | 1 | — |
| +10 | K213102 | ES1 System | E-Scopics | 2022 | 3 | — |
| +10 | K213544 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2022 | 6 | — |
| +10 | K213275 | EchoGo Core (2.0) | Ultromics Limited | 2021 | 1 | — |
| +10 | K212466 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2021 | 1 | — |
| +10 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | Ge Medical Systems, LLC | 2021 | 1 | — |
| +10 | K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | 3 | — |
| +10 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | 13 | — |
| +10 | K211300 | X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | 2021 | 3 | — |
| +10 | K211299 | X-CUBE 70 | Alpinion Medical Systems Co., Ltd. | 2021 | 3 | — |
| +10 | K212035 | FibroScan 230 | Echosens | 2021 | 5 | — |
| +10 | K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | 4 | — |
| +10 | K211337 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | 0 | — |
| +10 | K210959 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | 2 | — |
| +10 | K211216 | Vivid S60N / Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021 | 3 | 2 |
| +10 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | 1 | — |
| +10 | K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | 0 | — |
| +10 | K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3… | Edan Instruments, Inc. | 2021 | 0 | — |
| +10 | K201768 | Voluson E10 | GE Healthcare | 2020 | 4 | — |
| +10 | K200603 | AAA Model | Philips Ultrasound, Inc. | 2020 | 0 | — |
| +10 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | 2020 | 21 | 8 |
| +10 | K201352 | 3D Auto LAA | Philips Health Care | 2020 | 0 | — |
| +10 | K201597 | Liver Incytes, Model 1005 | Sonic Incytes | 2020 | 4 | — |
| +10 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And | 2020 | 7 | — |
| +10 | K200356 | Medo Aria | Medo.Ai | 2020 | 3 | — |
| +10 | K200158 | Logiq E10 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2020 | 12 | — |
| +10 | K200119 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 9 | — |
| +10 | K192030 | RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | 0 | — |
| +10 | K192159 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2019 | 5 | — |
| +10 | K183456 | Aloka Arietta 850 | Hitachi Healthcare Americas | 2019 | 2 | 3 |
| +10 | K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | 2018 | 1 | — |
| +10 | K181376 | Arietta 65 | Hitachi Healthcare Americas Corporation | 2018 | 3 | 1 |
| +10 | K181098 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | 19 | — |
| +10 | K180535 | Voluson P6 and Voluson P8 | GE Healthcare | 2018 | 12 | 1 |
| +10 | K172256 | SoftVue | Delphinus Medical Technologies | 2018 | 0 | — |
| +10 | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017 | 15 | — |
| +10 | K172142 | FibroScan 430 Mini+ | Echosens | 2017 | 0 | — |
| +10 | K162372 | QT Ultrasound Breast Scanner-1 | Qt Ultrasound, LLC | 2017 | 4 | — |
| +10 | K170303 | E5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017 | 0 | — |
| +10 | K163427 | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2017 | 0 | — |
| +10 | K160283 | S45 Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | 2016 | 15 | — |
| +10 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015 | 154 | — |
| +11 | K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026 | 0 | — |
| +11 | K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | 2026 | 0 | — |
| +11 | K252332 | Folliscan | Mim Fertility | 2026 | 0 | — |
| +11 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | 2026 | 0 | — |
| +11 | K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | 0 | — |
| +11 | K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2025 | 0 | — |
| +11 | K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 1 | — |
| +11 | K250330 | 3mensio Workstation | Pie Medical Imaging BV | 2025 | 0 | 1 |
| +11 | K252007 | BlineSlide | Deep Breathe, Inc. | 2025 | 0 | — |
| +11 | K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | — |
| +11 | K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | — |
| +11 | K243331 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2025 | 0 | — |
| +11 | K241659 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC | 2025 | 0 | — |
| +11 | K242800 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound, LLC | 2024 | 0 | — |
| +11 | K240980 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2024 | 0 | — |
| +11 | K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2024 | 2 | — |
| +11 | K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800… | Canon Medical Systems Corporation | 2024 | 0 | — |
| +11 | K240953 | AI Platform 2.0 (AIP002) | Exo Imaging | 2024 | 1 | — |
| +11 | K234141 | AISAP Cardio V1.0 | Aisap | 2024 | 0 | — |
| +11 | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2024 | 3 | — |
| +11 | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.Ai, Co., Ltd. | 2024 | 2 | — |
| +11 | K240769 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2024 | 0 | — |
| +11 | K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | 2024 | 14 | — |
| +11 | K233692 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | 0 | — |
| +11 | K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | 2024 | 2 | — |
| +11 | K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | 2024 | 3 | — |
| +11 | K231941 | ARIETTA x10 | FUJIFILM Healthcare Americas Corporation | 2023 | 0 | — |
| +11 | K231685 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023 | 2 | — |