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 |
| K240791 | Adas3D Medical S.L | ADAS 3D | 09/09/2024 |
| K232440 | Adra Corporation | Adravision Perio | 12/05/2023 |
| K230534 | Aidoc Medical, Ltd. | BriefCase-Quantification | 11/08/2023 |
| K232083 | Aidoc Medical, Ltd. | BriefCase-Quantification | 11/13/2023 |
| K241112 | Aidoc Medical, Ltd. | BriefCase-Quantification | 05/15/2024 |
| K242203 | Aidoc Medical, Ltd. | BriefCase-Quantification | 11/22/2024 |
| 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 |
| K243038 | Artrya Limited | Salix Central | 03/27/2025 |
| K243005 | Audax d.o.o. | AudaxCeph Cephalogram Analysis Software | 05/30/2025 |
| K240094 | Augmedit B.V. | LumiNE US; Lumi | 09/10/2024 |
| K222745 | Axial Medical Printing Limited | Axial3D Insight | 07/03/2023 |
| K232841 | Axial Medical Printing Limited | Axial3D Insight | 11/15/2023 |
| K240943 | BodyVision Medical Ltd. | LungVision | 10/01/2024 |
| K243633 | Brainlab AG | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | 06/13/2025 |
| 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 |
| K243810 | Brainlab Ltd. | TraumaCad Neo (1.1) | 06/04/2025 |
| K243684 | BrightHeart | BrightHeart View Classifier | 05/07/2025 |
| K251456 | BrightHeart | BrightHeart View Classifier | 06/05/2025 |
| K243779 | BunkerHill Health | Bunkerhill Abdominal Aortic Quantification (AAQ) | 07/01/2025 |
| K250328 | Canon Medical Systems Corporation | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | 04/30/2025 |
| K200621 | Caption Health | Caption Interpretation Automated Ejection Fraction Software | 07/22/2020 |
| K210747 | Caption Health | Caption Interpretation Automated Ejection Fraction Software | 01/19/2022 |
| K231955 | Carlsmed, Inc. | aprevo« Digital Segmentation | 11/03/2023 |
| K211611 | CASIS Cardiac Simulation & Imaging Software | QIR Suite | 09/30/2022 |
| K222676 | Ceevra, Inc. | Ceevra Reveal 3 | 04/25/2023 |
| K233568 | Ceevra, Inc. | Ceevra Reveal 3+ | 12/05/2023 |
| K243933 | Ceevra, Inc. | Ceevra Reveal 3+ | 03/04/2025 |
| K210719 | Change Healthcare Canada Company | Change Healthcare Anatomical AI | 07/20/2021 |
| K241038 | Circle Cardiovascular Imaging | Cardiac CT Function Software Application | 06/07/2024 |
| K213998 | Circle Cardiovascular Imaging Inc | cvi42 Auto Imaging Software Application | 07/28/2022 |
| K242781 | Circle Cardiovascular Imaging Inc. | cvi42 Software Application | 10/15/2024 |
| K203785 | ClariPi Inc. | ClariSIGMAM | 09/10/2021 |
| K222406 | Clarius Mobile Health Corp. | Clarius AI | 01/23/2023 |
| K232257 | Clarius Mobile Health Corp. | Clarius Bladder AI | 11/13/2023 |
| K250226 | Clarius Mobile Health Corp. | Clarius Median Nerve AI | 05/08/2025 |
| K243853 | Clarius Mobile Health Corp. | Clarius Prostate AI | 04/16/2025 |
| K213645 | ClearPoint Neuro, Inc. | ClearPoint Maestro Brain Model | 08/08/2022 |
| K242338 | Cleerly, Inc. | Cleerly LABS (v2.0) | 03/07/2025 |
| K243689 | Coreline Soft Co., Ltd. | AVIEW | 03/19/2025 |
| K243696 | Coreline Soft Co., Ltd. | AVIEW CAC | 02/14/2025 |
| K233211 | Coreline Soft Co., Ltd. | AVIEW CAC | 03/29/2024 |
| K214036 | Coreline Soft Co.,Ltd. | AVIEW | 12/23/2022 |
| K210831 | CorTechs Labs, Inc | OnQ Neuro | 11/19/2021 |
| K241098 | CorTechs Labs, Inc. | NeuroQuant | 08/22/2024 |
| K250754 | CureMetrix, Inc. | cmAngio« (V1.6) | 04/10/2025 |
| K232367 | CureMetrix, Inc. | cmAngio« V1.0 | 10/05/2023 |
| K212012 | Cycle Clarity | Follicle Clarity | 01/19/2022 |
| K231324 | DASI Simulations | DASI Dimensions (V1.0) | 01/08/2024 |
| K243705 | DeepHealth, Inc | Saige-Density (2.5.0) | 12/19/2024 |
| 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 |
| K240769 | DiA Imaging Analysis Ltd. | LVivo IQS | 05/24/2024 |
| K243331 | DiA Imaging Analysis Ltd. | LVivo Seamless | 03/06/2025 |
| K243862 | DiA Imaging Analysis Ltd. | LVivo Software Application | 03/17/2025 |
| K243235 | DiA Imaging Analysis Ltd. | LVivo Software Application | 03/03/2025 |
| K240553 | DiA Imaging Analysis Ltd. | LVivo Software Application | 10/04/2024 |
| K223757 | Disior Ltd | Bonelogic | 12/08/2023 |
| K240642 | Disior Ltd | SMART Bun-Yo-Matic CT | 06/20/2024 |
| K240736 | Disior Ltd | SMART Bun-Yo-Matic X-Ray | 07/02/2024 |
| K220956 | Dyad Medical, Inc | Libby Echo:Prio | 07/20/2022 |
| K233676 | Eko.ai Pte. Ltd d/b/a Us2.ai | Us2.v2 | 04/01/2024 |
| 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 |
| K231917 | EOS imaging | VEA Align | 01/05/2024 |
| K240582 | EOS imaging | VEA Align; spineEOS | 06/25/2024 |
| K212624 | Ever Fortune. AI Co., Ltd. | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | 04/04/2022 |
| K234042 | Ever Fortune.AI Co., Ltd. | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | 06/07/2024 |
| K250005 | Ewoosoft Co., Ltd | Clever One | 05/23/2025 |
| K231757 | Ewoosoft Co., Ltd | Ez3D-i /E3 | 07/14/2023 |
| K240953 | Exo Imaging | AI Platform 2.0 (AIP002) | 08/05/2024 |
| K232501 | Exo Inc | AI Platform (AIP001) | 11/17/2023 |
| K230497 | Exo Inc | Bladder AI (AIBV01) | 06/22/2023 |
| K242359 | Exo Inc | Strain AI (SAI001) | 11/20/2024 |
| K192969 | Ezra AI Inc. | Ezra Plexo Software | 07/10/2020 |
| K242334 | Ezra AI, Inc. | Ezra Flash | 01/02/2025 |
| K223855 | FEops nv | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | 06/06/2023 |
| K241982 | Foqus Technologies Inc. | DeepFoqus (DeepFoqus-Accelerate) | 04/04/2025 |
| K213272 | Formus Labs, Ltd | Formus Hip | 03/31/2023 |
| K243762 | FUJIFILM Corporation | Synapse 3D Base Tools (V7.0) | 05/21/2025 |
| K243647 | FUJIFILM Healthcare Americas Corporation | Synapse PACS (7.5) | 06/30/2025 |
| K250416 | Galileo CDS, Inc | GBrain MRI | 04/11/2025 |
| K251342 | GE Medical Systems Ultrasound and Primary Care Diagnostics | EchoPAC Software Only / EchoPAC Plug-in | 07/16/2025 |
| 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 |
| K240172 | Genesis Software Innovations | Preview Shoulder | 04/04/2024 |
| K241593 | Gleamer SAS | BoneMetrics (US) | 02/05/2025 |
| K240786 | HeartLung Corporation | AutoChamber | 10/10/2024 |
| K241984 | Hi-D Imaging AG | Hi-D Imaging 4TAVR | 04/02/2025 |
| K231690 | HighRAD Ltd. | iCAS-LV | 03/01/2024 |
| K233457 | Hutom Inc. | RUS | 07/12/2024 |
| 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 |
| K241430 | iCardio.ai | EchoMeasure | 10/10/2024 |
| K241847 | Imbio, Inc | Imbio PHA (4.0.0) | 08/30/2024 |
| K203256 | Imbio, LLC | Imbio RV/LV Software | 03/09/2021 |
| K230913 | Imeka Solutions, Inc. | ANDI | 07/25/2023 |
| K231683 | inHEART, SAS | inHEART Models | 02/29/2024 |
| K232613 | Innolitics, LLC | CT Cardiomegaly | 02/28/2024 |
| K242461 | Intuitive Surgical Inc. | IRISeg | 12/10/2024 |
| K232331 | InVision Medical Technology Corporation | InVision Precision LVEF (LVEF) | 04/25/2024 |
| K223396 | iSchema View Inc. | Rapid RV/LV | 02/01/2023 |
| K243378 | iSchemaview Inc. | Rapid MLS | 05/28/2025 |
| K233512 | iSchemaView, Inc. | Rapid (6.0) | 01/16/2024 |
| K243350 | iSchemaView, Inc. | Rapid Neuro3D | 01/22/2025 |
| K233196 | JLK Inc. | Medihub Prostate | 06/21/2024 |
| K242500 | LARALAB GmbH | LARALAB | 04/16/2025 |
| 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 |
| K234009 | Mighty Oak Medical | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | 07/12/2024 |
| K202404 | MRIguidance B.V | BoneMRI | 12/22/2021 |
| K233030 | MRIguidance B.V | BoneMRI | 03/01/2024 |
| K230197 | MRIguidance B.V. | BoneMRI v1.6 | 02/22/2023 |
| K233822 | MRIMath LLC | i2Contour | 08/08/2024 |
| K221762 | MRlguidance B.V. | BoneMRI v1.4 | 11/16/2022 |
| K240793 | MSKai | MSKai | 12/16/2024 |
| K250670 | Mycardium AI Limited | EchoConfidence (USA) | 06/30/2025 |
| K221738 | Neosoma Inc. | NS-HGlio | 09/27/2022 |
| K242215 | Neurophet, Inc. | Neurophet AQUA (V3.1) | 10/25/2024 |
| K211431 | Olea Medical | breastscape v1.0 | 08/02/2021 |
| K240645 | Ontact Health Co., Ltd | Sonix Health | 11/27/2024 |
| K230209 | Ontact Health Co., Ltd. | Sonix Health | 10/20/2023 |
| K241696 | Ortho AI LLC | Ortho AI | 01/02/2025 |
| K242270 | Orthofix Srl | OrthoNext Platform System | 12/19/2024 |
| K241681 | Overjet Inc | Overjet Image Enhancement Assist | 09/09/2024 |
| K233590 | Overjet, Inc | Overjet Charting Assist | 02/23/2024 |
| K241684 | Overjet, Inc | Overjet Charting Assist | 08/27/2024 |
| K240680 | Oxford Brain Diagnostics Ltd | CDM Insights | 12/06/2024 |
| K243230 | Pearl Inc. | Second Opinion« BLE | 05/09/2025 |
| K243989 | Pearl, Inc. | Second Opinion« 3D | 05/23/2025 |
| K250042 | Peek Health, S.A. | PeekMed web | 03/19/2025 |
| K251096 | Peek Health, S.A. | PeekMed web | 07/14/2025 |
| K241922 | Phantomics Inc. | Myomics | 02/28/2025 |
| K191647 | Philips Healthcare | QLAB Advanced Quantification Software | 12/20/2019 |
| K200974 | Philips Healthcare | QLAB Advanced Quantification Software | 06/03/2020 |
| K241659 | Philips Ultrasound LLC | Ultrasound Workspace (UWS 6.0) | 02/10/2025 |
| K240036 | PIUR Imaging GmbH | PIUR tUS Infinity | 09/20/2024 |
| K250484 | PIUR Imaging GmbH | PIUR tUS inside | 06/30/2025 |
| K241280 | Q Bio, Inc. | Constellation (CON-001) | 09/12/2024 |
| K232231 | Quibim S.L. | QP-Brain« | 12/13/2023 |
| K240740 | Qure.ai Technologies | qCT LN Quant | 08/16/2024 |
| 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 |
| K242054 | Rebrain, SAS | OptimMRI (v2) | 08/12/2024 |
| K233925 | Relu BV | Relu Creator | 06/13/2024 |
| K241108 | Remedy Logic Inc. | RemedyLogic AI MRI Lumbar Spine Reader | 10/30/2024 |
| K243863 | Roche Molecular Systems, Inc. | OpulusÖ Lymphoma Precision | 05/30/2025 |
| K242607 | ScanDiags AG | ScanDiags Ortho L-Spine MR-Q | 02/21/2025 |
| K232096 | Screenpoint Medical B.V. | Transpara Density 1.0.0 | 12/11/2023 |
| K230039 | Shanghai United Imaging Healthcare Co., Ltd | uOmnispace | 07/20/2023 |
| K192601 | Shanghai United Imaging Healthcare Co., Ltd | uWS-MR | 06/01/2020 |
| K242624 | Shanghai United Imaging Healthcare Co., Ltd. | Medical Image Post-processing Software (uOmnispace.CT) | 05/14/2025 |
| K233209 | Shanghai United Imaging Healthcare Co., Ltd. | uOmnispace.CT | 05/17/2024 |
| K233186 | Shanghai United Imaging Healthcare Co., Ltd. | uOmnispace.MR | 04/17/2024 |
| K240411 | Shanghai United Imaging Intelligence Co., Ltd. | uAI Portal | 09/06/2024 |
| K213706 | Siemens Healthcare GmBh | AI-Rad Companion Brain MR | 04/15/2022 |
| K232856 | Siemens Healthcare GmbH | Syngo Carbon Clinicals | 12/01/2023 |
| K242551 | Siemens Healthcare GmbH | syngo Dynamics (Version VA41D) | 04/03/2025 |
| K232305 | Siemens Medical Solutions U.S.A. | AI-Rad Companion Brain MR | 10/23/2023 |
| K193283 | Siemens Medical Solutions USA Inc. | AI-Rad Companion Prostate MR | 07/30/2020 |
| K242300 | Siemens Medical Solutions USA, Inc. | MI View&GO | 08/30/2024 |
| 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 |
| K232000 | Siemens Medical Solutions USA, Inc. | syngo.via MI Workflows; Scenium; syngo MBF | 11/28/2023 |
| K242275 | Siemens Medical Solutions USA, Inc. | syngo.via MI Workflows; Scenium; syngo MBF | 08/30/2024 |
| K251528 | Siemens Medical Solutions USA, Inc. | syngo.via MI Workflows; Scenium; syngo MBF | 07/03/2025 |
| K231130 | SimBioSys, Inc. | TumorSight Viz | 12/26/2023 |
| K251766 | SimBioSys, Inc. | TumorSight Viz | 07/08/2025 |
| K243189 | SimBioSys, Inc. | TumorSight Viz | 10/25/2024 |
| K241211 | Smart Soft Healthcare | CoLumbo | 08/15/2024 |
| K220497 | Smart Soft Healthcare AD | CoLumbo | 06/23/2022 |
| K250367 | Smart Soft Healthcare AD | CoLumboX | 05/28/2025 |
| K232698 | Software Nemotec S.L. | NemoScan | 01/18/2024 |
| K251009 | Sora Neuroscience, Inc. | Cirrus Resting State fMRI Software | 06/06/2025 |
| K230045 | Stryker Corp. | HipCheck | 09/29/2023 |
| K243250 | Subtle Medical, Inc. | SubtleHD (1.x) | 02/12/2025 |
| K241329 | Subtle Medical, Inc. | SubtleSYNTH (1.x) | 07/11/2024 |
| K241083 | Surgical Information Sciences, Inc. | SIS System | 06/14/2024 |
| K230977 | Surgical Information Sciences, Inc. | SIS System | 05/02/2023 |
| K223032 | Surgical Information Sciences, Inc. | SIS System (Version 5.6.0) | 11/21/2022 |
| K231929 | Sydney Neuroimaging Analysis Centre Pty Ltd | iQ-solutions | 12/18/2023 |
| K222174 | Synapsica | RadioLens v1.0 | 03/28/2023 |
| K243158 | TeraRecon, Inc. | TeraRecon Aorta.CT (1.1.0) | 01/23/2025 |
| K241312 | TeraRecon,Inc. | TeraRecon Cardiac.Chambers.MR (1.0.0) | 11/05/2024 |
| K241561 | Therapixel | MammoScreen BD | 10/02/2024 |
| K213544 | TOMTEC Imaging Systems GmbH | TOMTEC-ARENA | 01/06/2022 |
| K242166 | TribusMed Beheer BV | TribusConnect | 03/31/2025 |
| K213275 | Ultromics Limited | EchoGo Core (2.0) | 12/20/2021 |
| K191171 | Ultromics Ltd | EchoGo Core | 11/13/2019 |
| K241961 | Vent Creativity | Vent Creativity Knee v1.0 (Hermes) | 03/20/2025 |
| K241222 | Ventripoint Diagnostics Ltd. | Ventripoint Medical System Plus (VMS+) 4.0 | 02/26/2025 |
| K223296 | VideaHealth, Inc. | Videa Perio Assist | 02/06/2023 |
| K241543 | VinBrain Joint Stock Company | DrAidÖ for Liver Segmentation | 12/06/2024 |
| K201411 | Visage Imaging GmbH | Visage Breast Density | 01/29/2021 |
| K232363 | Viz.ai, Inc. | Viz HDS, Viz Volume Plus, Viz ICH+ | 02/05/2024 |
| K221100 | Viz.ai, Inc. | Viz RV/LV | 08/29/2022 |
| K250354 | Viz.ai, Inc. | Viz Subdural+, Viz SUBDURAL PLUS | 06/10/2025 |
| 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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