Devices descending from K012926
55 later devices reach Modification to Ensite 3000 System, Model EE3000 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | 54 | — |
| +2 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | 52 | — |
| +2 | K033211 | Ensite System | Endocardial Solutions, Inc. | 2003 | 0 | — |
| +3 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | 51 | — |
| +4 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches… | Biosense Webster, Inc. | 2007 | 47 | — |
| +4 | K070902 | Modification to: Ensite System, Model, EE3000 | St Jude Medical | 2007 | 7 | — |
| +5 | K130750 | Rhythmia Mapping System | Rhythmia Medical, Inc. | 2013 | 4 | — |
| +5 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 45 | 4 |
| +5 | K083328 | Ensite System, Model EE3000, and Ensite Navx Surface Electrode, Model EN0010 | St Jude Medical | 2009 | 0 | — |
| +5 | K071818 | Ensite Fusion Dynamic Registration Tool | St Jude Medical | 2007 | 0 | — |
| +6 | K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2017 | 3 | — |
| +6 | K093566 | Carto XP EP Navigation System, Version 10 | Biosense Webster, Inc. | 2010 | 14 | — |
| +6 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 34 | 1 |
| +7 | K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | 2024 | 0 | — |
| +7 | K201298 | VX1 | Volta Medical | 2020 | 8 | — |
| +7 | K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation | 2018 | 2 | — |
| +7 | K132782 | CARTO3 EP Navigation System, Version 3.2 | Biosense Webster, Inc. | 2014 | 4 | 1 |
| +7 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation… | Biosense Webster, Inc. | 2011 | 33 | 1 |
| +8 | K250749 | PhysCade System | Physcade, Inc. | 2025 | 0 | — |
| +8 | K232616 | Volta AF-Xplorer | Volta Medical | 2023 | 2 | — |
| +8 | K223516 | VX1+ | Volta Medical | 2023 | 4 | — |
| +8 | K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd. | 2022 | 0 | — |
| +8 | K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | 2021 | 1 | — |
| +8 | K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | 2019 | 1 | — |
| +8 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 32 | 2 |
| +9 | K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025 | 0 | — |
| +9 | K243812 | Volta AF-Xplorer | Volta Medical | 2025 | 1 | — |
| +9 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 31 | 2 |
| +10 | K251518 | Volta AF-Xplorer II | Volta Medical | 2025 | 0 | — |
| +10 | K152160 | Navik 3D | Apn Health, LLC | 2016 | 0 | 1 |
| +10 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 27 | 2 |
| +11 | K233160 | NeuTrace EP Mapping System v.2.1 | Anumana, Inc. | 2023 | 0 | — |
| +11 | K180940 | KODEX EPD System | Philips Medical Systems Nederland B.V. | 2018 | 1 | — |
| +11 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster, Inc. | 2018 | 0 | — |
| +11 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | Biosense Webster, Inc. | 2018 | 0 | — |
| +11 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | 20 | — |
| +12 | K212493 | KODEX – EPD™ System 1.5.0 | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022 | 0 | — |
| +12 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | 19 | — |
| +13 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | 16 | 1 |
| +14 | K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 | 14 | — |
| +14 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | 15 | — |
| +15 | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart… | Medtronic, Inc. | 2024 | 5 | — |
| +15 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | Biosense Webster, Inc. | 2023 | 6 | — |
| +15 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Biosense Webster, Inc. | 2022 | 0 | — |
| +16 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | 2024 | 4 | — |
| +16 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | 2023 | 5 | — |
| +17 | K252164 | NorthStar™ Mapping System | Imricor Medical Systems | 2026 | 1 | — |
| +17 | K252302 | CARTO™ 3 EP Navigation System V8.1 | Biosense Webster, Inc. | 2025 | 2 | — |
| +17 | K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025 | 0 | — |
| +17 | K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025 | 1 | — |
| +17 | K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024 | 0 | — |
| +18 | K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026 | 0 | — |
| +18 | K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026 | 0 | — |
| +18 | K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026 | 0 | — |
| +18 | K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026 | 0 | — |