Devices descending from K980851
83 later devices reach Galaxy Intravascular Ultrasound System, Model I5028 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K151126 | Foresight Intracardiac Echocardiography (ICE) System | Colibri Technologies, Inc. | 2015 | 1 | — |
| +1 | K121913 | Reprocessed Ultrasound Intracardiac Echo Catheter | Stryker Sustainability Solutions, Inc. | 2012 | 0 | — |
| +1 | K093857 | C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories | Lightlab Imaging, Inc. | 2010 | 11 | — |
| +1 | K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 | Infraredx, Inc. | 2008 | 1 | — |
| +1 | K052348 | IN Vision Gold with Spin Vision, Model 891 SV | Volcano Corporation | 2005 | 29 | — |
| +1 | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | 36 | 2 |
| +1 | K024103 | Ivus Plus | Indec Systems, Inc. | 2003 | 0 | — |
| +2 | K162789 | Foresight Intracardiac Echocardiology (ICE) System | Conavi Medical, Inc. | 2017 | 0 | — |
| +2 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | 7 | — |
| +2 | K122878 | HD-Ivus Ultrasound Imaging System | Silicon Vally Medical Instruments, Inc. | 2013 | 3 | — |
| +2 | K112997 | HD-Ivus Ultrasound Imaging System | Silicon Vally Medical Instruments, Inc. | 2011 | 4 | — |
| +2 | K111201 | C7 XR Imaging System | Lightlab Imaging, Inc. | 2011 | 2 | — |
| +2 | K093993 | Lipiscan Ivus Imaging System Model Nirs-MC7-70 | Infraredx, Inc. | 2010 | 0 | — |
| +2 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 28 | 2 |
| +2 | K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corp | 2007 | 28 | 1 |
| +2 | K063493 | I Review Software (Accessory to) Ilab Ultrasound Imaging System) VERSION1.0 | Boston Scientific Corp | 2006 | 0 | 1 |
| +3 | K172258 | Novasight Hybrid System | Conavi Medical, Inc. | 2018 | 1 | Class I |
| +3 | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2017 | 2 | — |
| +3 | K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Avinger, Inc. | 2016 | 3 | — |
| +3 | K152275 | Pantheris System | Avinger, Inc. | 2015 | 6 | — |
| +3 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | Lightlab Imaging, Inc. | 2015 | 1 | — |
| +3 | K123535 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | 27 | — |
| +3 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System | Volcano Corporation | 2008 | 25 | 3 |
| +4 | K252945 | Novasight Hybrid System | Conavi Medical, Inc. | 2026 | 0 | — |
| +4 | K192267 | ILUMIEN System with AptiVue Software version D.3 | Abbott Medical | 2019 | 0 | — |
| +4 | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2019 | 1 | — |
| +4 | K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox… | Avinger, Inc. | 2017 | 2 | — |
| +4 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016 | 5 | — |
| +4 | K130243 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | 26 | — |
| +4 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 24 | 1 |
| +5 | K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Acist Medical Systems, Inc. | 2020 | 0 | Class I |
| +5 | K173862 | Pantheris System | Avinger, Inc. | 2018 | 1 | — |
| +5 | K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017 | 11 | — |
| +5 | K160827 | Pantheris Catheter | Avinger, Inc. | 2016 | 4 | — |
| +5 | K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2015 | 10 | — |
| +5 | K152403 | Permanent Sled Bag | Boston Scientific | 2015 | 0 | — |
| +5 | K152316 | iLab Ultrasound Imaging System | Boston Scientific | 2015 | 1 | — |
| +5 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 21 | 10 |
| +5 | K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure System | Volcano Corporation | 2012 | 2 | — |
| +6 | K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | 2025 | 0 | — |
| +6 | K212047 | Pantheris System | Avinger, Inc. | 2021 | 0 | — |
| +6 | K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2019 | 8 | 1 |
| +6 | K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | 9 | — |
| +6 | K181577 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | 0 | — |
| +6 | K170204 | FFR Link, FFR Signal Processing Module | Boston Scientific Corporation | 2017 | 0 | 1 |
| +6 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | 18 | — |
| +6 | K133142 | Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for… | Volcano Corporation | 2013 | 0 | — |
| +6 | K132659 | Volcano Preview Forward-Looking Ivus System | Volcano Corporation | 2013 | 0 | — |
| +6 | K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000… | Volcano Corporation | 2013 | 1 | — |
| +7 | K223812 | Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. | 2023 | 0 | 3 |
| +7 | K201178 | iLab Polaris Multi-Modality Guidance System | Boston Scientific | 2020 | 6 | — |
| +7 | K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | 8 | — |
| +7 | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | 2019 | 2 | — |
| +7 | K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019 | 3 | — |
| +7 | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound… | Volcano Corporation | 2018 | 4 | — |
| +7 | K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | Volcano Corporation | 2015 | 2 | — |
| +7 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | 9 | — |
| +7 | K143122 | Volcano iFR Harvest Software (Offline) | Volcano Corporation | 2015 | 0 | — |
| +8 | K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025 | 0 | — |
| +8 | K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 2024 | 0 | — |
| +8 | K232386 | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™… | Abbott Medical | 2023 | 0 | — |
| +8 | K220243 | Ultiri Measurement System | Abbott Medical | 2022 | 0 | — |
| +8 | K210889 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | 2021 | 4 | — |
| +8 | K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | 2020 | 1 | — |
| +8 | K201713 | AVVIGO Guidance System | Boston Scientific Corporation | 2020 | 4 | — |
| +8 | K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | 7 | — |
| +8 | K190078 | IntraSight | Volcano Corporation | 2019 | 2 | — |
| +8 | K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2… | Volcano Corporation | 2017 | 0 | 1 |
| +8 | K170133 | FFR V2.5 | Philips Volcano | 2017 | 5 | 1 |
| +8 | K170385 | CORE M2 Vascular System | Volcano Corporation | 2017 | 1 | — |
| +9 | K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026 | 0 | 1 |
| +9 | K212490 | AVVIGO Guidance System II | Boston Scientific Corporation | 2021 | 3 | — |
| +9 | K210680 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021 | 0 | — |
| +9 | K203719 | IntraSight Mobile | Volcano Corporation | 2021 | 0 | 1 |
| +9 | K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | 5 | — |
| +10 | K230884 | AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation | 2023 | 1 | 22 |
| +10 | K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console… | Boston Scientific Corporation | 2023 | 0 | — |
| +10 | K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021 | 4 | — |
| +11 | K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026 | 0 | — |
| +11 | K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022 | 3 | — |
| +12 | K222209 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022 | 2 | — |
| +13 | K231091 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023 | 0 | — |
| +13 | K230606 | AcQMap® High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2023 | 0 | — |