FDA 510(k) Applications for Medical Device Product Code "QIH"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221432 | 3D-Side SA | Customize | 08/03/2022 |
| K213779 | 3D-Side SA | Customize | 03/16/2022 |
| K223621 | Alpha Intelligence Manifolds, Inc. | DeepXray | 09/08/2023 |
| K203555 | AmCad BioMed Corporation | AmCAD-UT | 09/08/2021 |
| K192437 | Arterys Inc. | Arterys MICA | 03/25/2020 |
| K203744 | Arterys Inc. | Arterys MICA | 03/14/2022 |
| K222745 | Axial Medical Printing Limited | Axial3D Insight | 07/03/2023 |
| K223106 | Brainlab AG | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | 07/14/2023 |
| K200621 | Caption Health | Caption Interpretation Automated Ejection Fraction Software | 07/22/2020 |
| K210747 | Caption Health | Caption Interpretation Automated Ejection Fraction Software | 01/19/2022 |
| K211611 | CASIS Cardiac Simulation & Imaging Software | QIR Suite | 09/30/2022 |
| K222676 | Ceevra, Inc. | Ceevra Reveal 3 | 04/25/2023 |
| K210719 | Change Healthcare Canada Company | Change Healthcare Anatomical AI | 07/20/2021 |
| K213998 | Circle Cardiovascular Imaging Inc | cvi42 Auto Imaging Software Application | 07/28/2022 |
| K203785 | ClariPi Inc. | ClariSIGMAM | 09/10/2021 |
| K222406 | Clarius Mobile Health Corp. | Clarius AI | 01/23/2023 |
| K213645 | ClearPoint Neuro, Inc. | ClearPoint Maestro Brain Model | 08/08/2022 |
| K214036 | Coreline Soft Co.,Ltd. | AVIEW | 12/23/2022 |
| K210831 | CorTechs Labs, Inc | OnQ Neuro | 11/19/2021 |
| K232367 | CureMetrix, Inc. | cmAngio« V1.0 | 10/05/2023 |
| K212012 | Cycle Clarity | Follicle Clarity | 01/19/2022 |
| K222275 | DeepHealth, Inc. | Saige-Density | 12/16/2022 |
| K222970 | DiA Imaging Analysis Ltd | LVivo IQS | 02/01/2023 |
| K202546 | DiA Imaging Analysis Ltd | LVivo Seamless | 09/29/2020 |
| K212466 | DiA Imaging Analysis Ltd | LVivo Seamless | 12/09/2021 |
| K200232 | DiA Imaging Analysis Ltd | LVivo Software Application | 06/23/2020 |
| K210053 | DiA Imaging Analysis Ltd | LVivo Software Application | 02/05/2021 |
| K220956 | Dyad Medical, Inc | Libby Echo:Prio | 07/20/2022 |
| K210791 | eko.ai Pte. Ltd. d/b/a Us2.ai | Us2.v1 | 07/27/2021 |
| K223501 | Elaitra Ltd | ViewFinder Software Version 1.1 | 04/21/2023 |
| K212624 | Ever Fortune. AI Co., Ltd. | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | 04/04/2022 |
| K230497 | Exo Inc | Bladder AI (AIBV01) | 06/22/2023 |
| K192969 | Ezra AI Inc. | Ezra Plexo Software | 07/10/2020 |
| K223855 | FEops nv | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | 06/06/2023 |
| K213272 | Formus Labs, Ltd | Formus Hip | 03/31/2023 |
| K220940 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | EchoPAC Software Only, EchoPAC Plug-in | 07/22/2022 |
| K211161 | GE Medical Systems, LLC | Critical Care Suite with Endotracheal Tube Positing AI algorithm | 10/29/2021 |
| K210556 | Genesis Software Innovations | Preview Shoulder | 04/21/2021 |
| K220815 | Hyperfine, Inc. | BrainInsight | 07/19/2022 |
| K223268 | Hyperfine, Inc. | BrainInsight | 12/16/2022 |
| K223646 | IB Lab GmbH | IB Lab LAMA | 06/16/2023 |
| K211506 | iCAD, Inc. | PowerLook Density Assessment V4.0 | 07/12/2021 |
| K203256 | Imbio, LLC | Imbio RV/LV Software | 03/09/2021 |
| K230913 | Imeka Solutions, Inc. | ANDI | 07/25/2023 |
| K223396 | iSchema View Inc. | Rapid RV/LV | 02/01/2023 |
| K221632 | Medical Metrics, Inc. | Spine CAMPÖ | 10/18/2022 |
| K231668 | Medical Metrics, Inc. | Spine CAMPÖ (1.1) | 07/07/2023 |
| K223556 | MEDICALIP Co., Ltd | DeepCatch | 06/16/2023 |
| K222036 | Medipixel, Inc. | MPXA-2000 | 03/22/2023 |
| K203502 | MEDO DX Pte. Ltd. | MEDO-Thyroid | 04/23/2021 |
| K200356 | Medo.ai | MEDO ARIA | 06/11/2020 |
| K202404 | MRIguidance B.V | BoneMRI | 12/22/2021 |
| K230197 | MRIguidance B.V. | BoneMRI v1.6 | 02/22/2023 |
| K221762 | MRlguidance B.V. | BoneMRI v1.4 | 11/16/2022 |
| K221738 | Neosoma Inc. | NS-HGlio | 09/27/2022 |
| K211431 | Olea Medical | breastscape v1.0 | 08/02/2021 |
| K191647 | Philips Healthcare | QLAB Advanced Quantification Software | 12/20/2019 |
| K200974 | Philips Healthcare | QLAB Advanced Quantification Software | 06/03/2020 |
| K211222 | Qure.ai Technologies | qER-Quant | 07/30/2021 |
| K212690 | Qure.ai Technologies | qXR-BT | 12/21/2021 |
| K231149 | Qure.ai Technologies | qXR-CTR | 09/22/2023 |
| K230150 | RebrAIn, SAS | OptimMRI | 07/21/2023 |
| K230039 | Shanghai United Imaging Healthcare Co., Ltd | uOmnispace | 07/20/2023 |
| K192601 | Shanghai United Imaging Healthcare Co., Ltd | uWS-MR | 06/01/2020 |
| K213706 | Siemens Healthcare GmBh | AI-Rad Companion Brain MR | 04/15/2022 |
| K193283 | Siemens Medical Solutions USA Inc. | AI-Rad Companion Prostate MR | 07/30/2020 |
| K222172 | Siemens Medical Solutions USA, Inc. | MI View&GO | 08/19/2022 |
| K222428 | Siemens Medical Solutions USA, Inc. | Syngo Dynamics (Version VA40F) | 11/14/2022 |
| K211459 | Siemens Medical Solutions USA, Inc. | syngo.via MI WorkFlows, Scenium, syngo MBF | 06/10/2021 |
| K201195 | Siemens Medical Solutions USA, Inc. | syngo.via MI Workflows, syngo MBF | 11/18/2020 |
| K220497 | Smart Soft Healthcare AD | CoLumbo | 06/23/2022 |
| K230045 | Stryker Corp. | HipCheck | 09/29/2023 |
| K230977 | Surgical Information Sciences, Inc. | SIS System | 05/02/2023 |
| K223032 | Surgical Information Sciences, Inc. | SIS System (Version 5.6.0) | 11/21/2022 |
| K222174 | Synapsica | RadioLens v1.0 | 03/28/2023 |
| K213544 | TOMTEC Imaging Systems GmbH | TOMTEC-ARENA | 01/06/2022 |
| K213275 | Ultromics Limited | EchoGo Core (2.0) | 12/20/2021 |
| K191171 | Ultromics Ltd | EchoGo Core | 11/13/2019 |
| K223296 | VideaHealth, Inc. | Videa Perio Assist | 02/06/2023 |
| K201411 | Visage Imaging GmbH | Visage Breast Density | 01/29/2021 |
| K221100 | Viz.ai, Inc. | Viz RV/LV | 08/29/2022 |
| K231398 | VUNO Inc. | VUNO Med-DeepBrain | 10/04/2023 |
| K202013 | Whiterabbit.ai Inc. | WRDensity by Whiterabbit.ai | 10/30/2020 |
| K213986 | Yukun (Beijing) Technology Co., Ltd | CerebralGo Plus | 04/13/2023 |
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