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 |
|---|---|---|---|---|---|---|
| +9 | K203699 | syngo. CT Extended Functionalities | Siemens Medical Solutions USA, Inc. | 2021 | 3 | — |
| +9 | K202928 | DV. Target | Deepvoxel, Inc. | 2021 | 0 | — |
| +9 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 5 | 8 |
| +9 | K202074 | Apache Ultrasound System (Model C62) | Compal Electronics, Inc. | 2020 | 0 | — |
| +9 | K201352 | 3D Auto LAA | Philips Health Care | 2020 | 0 | — |
| +9 | K192969 | Ezra Plexo Software | Ezra Ai, Inc. | 2020 | 0 | — |
| +9 | K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | 2020 | 1 | — |
| +9 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | 6 | — |
| +9 | K200356 | Medo Aria | Medo.Ai | 2020 | 3 | — |
| +9 | K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020 | 12 | — |
| +9 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series… | Philips Ultrasound, Inc. | 2020 | 18 | 5 |
| +9 | K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020 | 24 | 3 |
| +9 | K190042 | Brainlab Elements Image Fusion Angio | Brainlab AG | 2019 | 0 | — |
| +9 | K182601 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | 0 | — |
| +9 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | 9 | — |
| +9 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7… | Philips Ultrasound, Inc. | 2018 | 19 | 23 |
| +9 | K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 5 | — |
| +9 | K172999 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 4 | — |
| +9 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | 3 | — |
| +9 | K172998 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 2 | — |
| +9 | K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016 | 8 | — |
| +9 | K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016 | 8 | 4 |
| +9 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | 4 | — |
| +9 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 6 | 9 |
| +9 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | 46 | — |
| +9 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | 1 | — |
| +9 | K130552 | CT Pulmonary Analysis | Qi Imaging, LLC | 2014 | 2 | — |
| +9 | K123577 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2013 | 19 | — |
| +10 | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026 | 0 | — |
| +10 | K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026 | 0 | — |
| +10 | K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026 | 0 | — |
| +10 | K252332 | Folliscan | Mim Fertility | 2026 | 0 | — |
| +10 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | 2026 | 0 | — |
| +10 | K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2025 | 0 | — |
| +10 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | 0 | — |
| +10 | K243859 | PRAEVAorta®2 | Nurea | 2025 | 0 | — |
| +10 | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | 2025 | 0 | — |
| +10 | K250416 | GBrain MRI | Galileo Cds, Inc. | 2025 | 1 | — |
| +10 | K240680 | CDM Insights | Oxford Brain Diagnostics, Ltd. | 2024 | 0 | — |
| +10 | K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | 2024 | 0 | — |
| +10 | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.Ai, Co., Ltd. | 2024 | 2 | — |
| +10 | K241112 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2024 | 1 | — |
| +10 | K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Guangdong Youkey Medical Co., Ltd. | 2024 | 0 | — |
| +10 | K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2024 | 0 | — |
| +10 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 4 | — |
| +10 | K231509 | Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. | 2023 | 0 | — |
| +10 | K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2023 | 0 | — |
| +10 | K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2023 | 1 | 2 |
| +10 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking… | Brainlab AG | 2023 | 1 | — |
| +10 | K230023 | ART-Plan | Therapanacea Sas | 2023 | 3 | — |
| +10 | K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023 | 5 | — |
| +10 | K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500… | Philips Ultrasound, LLC | 2022 | 1 | 2 |
| +10 | K220590 | aPROMISE X | Exini Diagnostics AB | 2022 | 0 | — |
| +10 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | 1 | — |
| +10 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | 3 | — |
| +10 | K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021 | 5 | — |
| +10 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | 2021 | 17 | — |
| +10 | K200603 | AAA Model | Philips Ultrasound, Inc. | 2020 | 0 | — |
| +10 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | 2020 | 21 | 8 |
| +10 | K201632 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2020 | 10 | — |
| +10 | K192630 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | 1 | — |
| +10 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | 2 | — |
| +10 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | 8 | — |
| +10 | K183170 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | 4 | — |
| +10 | K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | 2019 | 10 | — |
| +10 | K190232 | Synapse PACS | Fujifilm Corporation | 2019 | 3 | 11 |
| +10 | K183164 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | 3 | — |
| +10 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 5 | 6 |
| +10 | K182208 | syngo.via View&GO (Version VA10A) | Siemens Healthcare GmbH | 2018 | 4 | — |
| +10 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | 7 | — |
| +10 | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | 1 | 2 |
| +10 | K171463 | ASPIRE Bellus II | Fujifilm Medical Systems U.S.A, Inc. | 2017 | 0 | — |
| +10 | K163668 | Suitestensa | Ebit Srl | 2017 | 0 | — |
| +10 | K170952 | syngo.CT View&GO | Siemens Medical Solutions USA, Inc. | 2017 | 3 | — |
| +10 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | 23 | — |
| +10 | K161685 | syngo®.via protoNeo (Version VA10A) | Siemens Healthcare GmbH | 2016 | 1 | — |
| +10 | K133644 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2014 | 18 | — |
| +11 | K262390 | BoneXpert | Visiana | 2026 | 0 | — |
| +11 | K251417 | ReVISION 2 | Argus Cognitive, Inc. | 2026 | 0 | — |
| +11 | K250914 | MediAI-BA | Crescom Co., Ltd. | 2025 | 0 | — |
| +11 | K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2025 | 0 | — |
| +11 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | 1 | — |
| +11 | K252362 | GBrain MRI | Galileo Cds, Inc. | 2025 | 0 | — |
| +11 | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | 1 | — |
| +11 | K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH | 2025 | 2 | Class I |
| +11 | K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image… | Brainlab AG | 2025 | 0 | — |
| +11 | K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 0 | — |
| +11 | K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | 2025 | 1 | — |
| +11 | K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | 2024 | 2 | — |
| +11 | K242203 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2024 | 0 | — |
| +11 | K242800 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound, LLC | 2024 | 0 | — |
| +11 | K240411 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | 2024 | 0 | — |
| +11 | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2024 | 3 | — |
| +11 | K233457 | RUS | Hutom, Inc. | 2024 | 0 | — |
| +11 | K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | 1 | — |
| +11 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2024 | 16 | 1 |
| +11 | K232479 | ART-Plan | Therapanacea | 2023 | 2 | — |
| +11 | K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 0 | — |
| +11 | K230039 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | 0 | — |
| +11 | K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | 0 | — |