Devices descending from K945512
525 later devices reach HRSW Option for CT Twin Flash through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | 2026 | 0 | — |
| +6 | K252029 | AI-CVD | HeartLung Corporation | 2025 | 0 | — |
| +6 | K250902 | HeartFlow Analysis | HeartFlow, Inc. | 2025 | 0 | — |
| +6 | K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | 2025 | 0 | 3 |
| +6 | K243672 | CardIQ Suite | GE Medical Systems SCS | 2025 | 1 | — |
| +6 | K244008 | Spectral CT | Philips Medical Systems Technologies, Ltd. | 2025 | 0 | 3 |
| +6 | K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 0 | 1 |
| +6 | K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 1 | 2 |
| +6 | K241524 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2024 | 0 | — |
| +6 | K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | 2024 | 1 | 5 |
| +6 | K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy… | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 1 | 3 |
| +6 | K231047 | UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | 2023 | 0 | — |
| +6 | K212758 | Autoplaque | Cedars-Sinai Medical Center: Aim | 2023 | 3 | — |
| +6 | K230393 | UniCam Evo Software | Inter Medical Medizintechnik GmbH | 2023 | 0 | — |
| +6 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 2 | — |
| +6 | K223311 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd. | 2022 | 0 | — |
| +6 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022 | 1 | — |
| +6 | K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | 2022 | 0 | 6 |
| +6 | K210760 | Precise Image | Philips Medical Systems Nederland B.V. | 2022 | 0 | — |
| +6 | K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | 1 | 1 |
| +6 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | 9 | — |
| +6 | K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | 0 | — |
| +6 | K201710 | A View LCS | Coreline Soft Co., Ltd. | 2020 | 0 | — |
| +6 | K192763 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2019 | 3 | — |
| +6 | K190868 | Cleerly Labs | Cleerly, Inc. | 2019 | 7 | — |
| +6 | K183143 | uCT 520, uCT 528 | Shangai United Imaging Healthcare Co., Ltd. | 2019 | 0 | — |
| +6 | K172418 | OpenSight | Novarad Corporation | 2018 | 5 | — |
| +6 | K172406 | Ingenuity TF | Philips Medical Systems (Cleveland), Inc. | 2017 | 0 | 3 |
| +6 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017 | 43 | — |
| +6 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | 45 | — |
| +6 | K170069 | AmCAD-UV | Amcad Biomed Corporation | 2017 | 0 | — |
| +6 | K161109 | iSR'obot MRI-US Fusion | Biobot Surgical Pte., Ltd. | 2016 | 2 | — |
| +6 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | 2 | — |
| +6 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 10 | 6 |
| +6 | K132524 | CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application | Philips Medical Systems | 2014 | 0 | 1 |
| +6 | K140651 | Celesteion, Pca-9000A/2 | Toshibamedical Systems Corporation | 2014 | 2 | 2 |
| +6 | K140138 | Heartnavigator Release 2.0 | Philips Medical Systems Nederland B.V. | 2014 | 2 | — |
| +6 | K132410 | Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 W | Ge Medical Systems, LLC | 2014 | 0 | 2 |
| +6 | K123599 | Ingenuity Digital Pet/CT | Philips Healthcare (Cleveland) | 2013 | 4 | 5 |
| +6 | K121296 | Interventional Workspot | Philips Medical Systems Nederland B.V. | 2013 | 1 | — |
| +6 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | 32 | — |
| +6 | K113086 | ACQA | Texas Medical Imaging Consultants | 2012 | 0 | — |
| +6 | K103483 | Ingenuity TF Pet/MR | Philips Healthcare (Cleveland) | 2011 | 0 | 4 |
| +6 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | 25 | — |
| +6 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | 1 | — |
| +6 | K093703 | 3DI | Shina Systems, Ltd. | 2010 | 2 | — |
| +6 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | 200 | — |
| +6 | K081792 | Spy Analysis Toolkit, Model SA9000 | Novadaq Technologies, Inc. | 2008 | 0 | — |
| +6 | K081426 | Nexstar Liftoff Pet Application Software Suite | Philips Medical Systems (Cleveland), Inc. | 2008 | 0 | — |
| +6 | K071241 | LMS-Liver | Median Technologies | 2007 | 9 | — |
| +6 | K052345 | Advantage Sim MD | GE Healthcare | 2005 | 21 | 3 |
| +7 | K253770 | CardIQ Suite | GE Medical Systems SCS | 2026 | 0 | — |
| +7 | K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | 2026 | 0 | — |
| +7 | K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | 0 | 1 |
| +7 | K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | 2025 | 0 | — |
| +7 | K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | 2025 | 0 | — |
| +7 | K243884 | Tavipilot | Caranx Medical | 2025 | 0 | — |
| +7 | K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy… | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 0 | 3 |
| +7 | K242240 | CaRi-Plaque | Caristo Diagnostics, Ltd. | 2025 | 1 | — |
| +7 | K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | 2024 | 0 | — |
| +7 | K241440 | HealthCCSng | Nano-X AI, Ltd. | 2024 | 0 | — |
| +7 | K231631 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | 0 | — |
| +7 | K230112 | CAC Software | Imbio, Inc. | 2023 | 0 | — |
| +7 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | 6 | — |
| +7 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | 1 | — |
| +7 | K213128 | IntraOp VSP Software Device | Xironetic, LLC | 2022 | 1 | — |
| +7 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 | 7 | — |
| +7 | K220146 | VisAR | Novarad Corporation | 2022 | 0 | — |
| +7 | K213411 | iSR’obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021 | 1 | — |
| +7 | K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021 | 2 | — |
| +7 | K210743 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 15 | 3 |
| +7 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | 17 | — |
| +7 | K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System… | Siemens Medical Solutions USA, Inc. | 2020 | 6 | — |
| +7 | K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | 2020 | 5 | — |
| +7 | K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 24 | 1 |
| +7 | K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2020 | 2 | — |
| +7 | K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 25 | — |
| +7 | K200713 | EchoNavigator | Philips Medical Systems Nederland B.V. | 2020 | 2 | — |
| +7 | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 26 | 1 |
| +7 | K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | Siemens Healthineers | 2019 | 26 | — |
| +7 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | 1 | — |
| +7 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | 44 | — |
| +7 | K181177 | Interventional Workspot | Philips Medical Systems Nederland B.V. | 2018 | 0 | — |
| +7 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2018 | 11 | — |
| +7 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | 28 | — |
| +7 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System… | Philips Health Care | 2017 | 28 | 31 |
| +7 | K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017 | 1 | — |
| +7 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 7 | 2 |
| +7 | K150665 | Philips Spectral CT Applications | Philips Medical Systems Nethrlands BV | 2015 | 1 | 1 |
| +7 | K132045 | Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options | Ge Hungary Kft | 2013 | 8 | — |
| +7 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | 36 | — |
| +7 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 8 | 1 |
| +7 | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | 0 | — |
| +7 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | 37 | — |
| +7 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | 76 | — |
| +7 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | 70 | — |
| +7 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | 54 | — |
| +8 | K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026 | 0 | — |
| +8 | K260748 | ES-Series | E-Scopics | 2026 | 0 | — |
| +8 | K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026 | 0 | — |