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 |
|---|---|---|---|---|---|---|
| +8 | K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026 | 0 | — |
| +8 | K250662 | Bunkerhill MAC | BunkerHill Health | 2025 | 0 | — |
| +8 | K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte., Ltd. | 2025 | 0 | — |
| +8 | K251837 | Salix Coronary Plaque (V1.0.0) | Artrya Limited | 2025 | 0 | — |
| +8 | K250120 | GECHO | Narnar, LLC | 2025 | 0 | — |
| +8 | K243069 | Lumys (V1) | Intradys | 2025 | 0 | — |
| +8 | K243038 | Salix Central | Artrya Limited | 2025 | 1 | — |
| +8 | K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | 2025 | 2 | — |
| +8 | K241922 | Myomics | Phantomics, Inc. | 2025 | 0 | — |
| +8 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | 3 | — |
| +8 | K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | 2024 | 0 | — |
| +8 | K243299 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024 | 0 | — |
| +8 | K242062 | 1CMR Pro | Mycardium AI Limited | 2024 | 0 | — |
| +8 | K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon,Inc. | 2024 | 0 | — |
| +8 | K241847 | Imbio PHA (4.0.0) | Imbio, Inc. | 2024 | 0 | — |
| +8 | K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023 | 0 | — |
| +8 | K232189 | OrionXR | Hoth Intelligence, Inc. | 2023 | 0 | — |
| +8 | K231420 | Aura 10 PET/CT | Xeos Medical | 2023 | 0 | — |
| +8 | K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023 | 0 | — |
| +8 | K223396 | Rapid RV/LV | Ischemaview, Inc. | 2023 | 1 | — |
| +8 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | 4 | — |
| +8 | K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2022 | 4 | — |
| +8 | K220624 | AI4CMR v1.0 | Ai4medimaging Medical Solutions S.A. | 2022 | 2 | — |
| +8 | K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022 | 6 | — |
| +8 | K221270 | EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. | 2022 | 1 | — |
| +8 | K221219 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2022 | 0 | — |
| +8 | K220779 | XD | Mirada Medical, Ltd. | 2022 | 0 | — |
| +8 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | 3 | — |
| +8 | K213370 | Veriqa | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022 | 0 | 2 |
| +8 | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022 | 0 | — |
| +8 | K213487 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022 | 1 | — |
| +8 | K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 4 | — |
| +8 | K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021 | 0 | — |
| +8 | K211859 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 7 | 1 |
| +8 | K202700 | ART-Plan | Therapanacea | 2021 | 5 | — |
| +8 | K200323 | AutoContour | Radformation, Inc. | 2020 | 7 | — |
| +8 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | 0 | — |
| +8 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 | 6 |
| +8 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | 41 | — |
| +8 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2019 | 10 | — |
| +8 | K191922 | ACUSON P200 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2019 | 23 | — |
| +8 | K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2019 | 6 | — |
| +8 | K190913 | QLAB Advanced Quantification Software 13 | Philips Health Care | 2019 | 1 | — |
| +8 | K181247 | Vitrea CT Brain Perfusion | Vital Images, Inc. | 2018 | 0 | — |
| +8 | K181646 | Celesteion, PCA-9000A/3, V6.5 | Canon Medical Systems Corporation | 2018 | 0 | — |
| +8 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound… | Philips Ultrasound, Inc. | 2018 | 27 | 24 |
| +8 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | 25 | — |
| +8 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | 11 | — |
| +8 | K173542 | Arterys Oncology DL | Arterys, Inc. | 2018 | 5 | — |
| +8 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature… | Brainlab AG | 2017 | 5 | — |
| +8 | K163250 | Longitudinal Brain Imaging (LoBI) application | Philips Medical Systems Nederland B.V. | 2017 | 0 | — |
| +8 | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | 5 | — |
| +8 | K161201 | ClearRead CT | Riverain Technologies, LLC | 2016 | 5 | — |
| +8 | K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016 | 2 | — |
| +8 | K153289 | Healthmyne | Healthmyne, Inc. | 2016 | 0 | — |
| +8 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | 9 | — |
| +8 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | 5 | — |
| +8 | K133521 | Aze Phoenix Software | Aze, Ltd. | 2014 | 0 | — |
| +8 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | 7 | — |
| +8 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | 63 | — |
| +8 | K113620 | Myrian 1.11 | Intrasense | 2012 | 6 | — |
| +8 | K120363 | Syngo RT Interface | Siemens Medical Solutions USA, Inc. | 2012 | 0 | — |
| +8 | K111861 | Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco Engine | Siemens Medical Systems USA | 2012 | 0 | — |
| +8 | K113244 | Synapse MPR Fusion | Fujifilm Medical System U.S.A., Inc. | 2011 | 9 | — |
| +8 | K113029 | Syngo Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2011 | 20 | — |
| +9 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound… | Philips Ultrasound, LLC | 2026 | 0 | — |
| +9 | K261210 | Cleerly Plaque | Cleerly, Inc. | 2026 | 0 | — |
| +9 | K260588 | Cleerly LABS | Cleerly, Inc. | 2026 | 0 | — |
| +9 | K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026 | 0 | — |
| +9 | K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | 2026 | 0 | — |
| +9 | K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | 0 | — |
| +9 | K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026 | 0 | — |
| +9 | K252084 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | 2026 | 0 | — |
| +9 | K243378 | Rapid MLS | Ischemaview, Inc. | 2025 | 0 | — |
| +9 | K242919 | V5med Lung AI | V5med, Inc. | 2025 | 0 | — |
| +9 | K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | 2025 | 2 | — |
| +9 | K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024 | 0 | — |
| +9 | K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024 | 0 | — |
| +9 | K232613 | CT Cardiomegaly | Innolitics, LLC | 2024 | 1 | — |
| +9 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | 3 | — |
| +9 | K231149 | qXR-CTR | Qure.Ai Technologies | 2023 | 0 | — |
| +9 | K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 3 | — |
| +9 | K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 5 | — |
| +9 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022 | 6 | — |
| +9 | K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2022 | 1 | — |
| +9 | K220813 | Art-Plan | Therapanacea | 2022 | 4 | — |
| +9 | K211665 | SONON Ultrasound Imaging System, Model: SONON300C | Healcerion Co., Ltd. | 2022 | 0 | — |
| +9 | K212915 | MVision AI Segmentation | MVision AI | 2022 | 1 | — |
| +9 | K212400 | SONON Ultrasound Imaging System, Model: SONON 500L | Healcerion Co., Ltd. | 2022 | 0 | — |
| +9 | K220490 | ImaCor Zura Handheld ZHH-010 | Imacor, Inc. | 2022 | 0 | 2 |
| +9 | K211746 | Pocket Ultrasound System | Guangdong Youkey Medical Co., Ltd. | 2022 | 1 | — |
| +9 | K212012 | Follicle Clarity | Cycle Clarity | 2022 | 1 | — |
| +9 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking… | Brainlab AG | 2021 | 3 | — |
| +9 | K213096 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2021 | 0 | — |
| +9 | K210831 | OnQ Neuro | Cortechs Labs, Inc. | 2021 | 3 | — |
| +9 | K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2021 | 2 | — |
| +9 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | Ge Medical Systems, LLC | 2021 | 1 | — |
| +9 | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | 2021 | 0 | — |
| +9 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | 1 | — |
| +9 | K211232 | Apache Ultrasound System | Aco Healthcare Co., Ltd. | 2021 | 0 | — |