QIH
319 FDA 510(k) clearances · Product code
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| uOmnispace.CT (K233209) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-17 |
| BriefCase-Quantification (K241112) | Aidoc Medical , Ltd. | 2024-05-15 |
| InVision Precision LVEF (LVEF) (K232331) | InVision Medical Technology Corporation | 2024-04-25 |
| uOmnispace.MR (K233186) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-17 |
| Preview Shoulder (K240172) | Genesis Software Innovations | 2024-04-04 |
| Us2.v2 (K233676) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2024-04-01 |
| AVIEW CAC (K233211) | Coreline Soft Co., Ltd. | 2024-03-29 |
| BoneMRI (K233030) | Mriguidance B.V. | 2024-03-01 |
| iCAS-LV (K231690) | Highrad , Ltd. | 2024-03-01 |
| inHEART Models (K231683) | Inheart, Sas | 2024-02-29 |
| CT Cardiomegaly (K232613) | Innolitics, LLC | 2024-02-28 |
| Overjet Charting Assist (K233590) | Overjet, Inc. | 2024-02-23 |
| Viz HDS, Viz Volume Plus, Viz ICH+ (K232363) | Viz. Ai, Inc. | 2024-02-05 |
| NemoScan (K232698) | Software Nemotec S.L. | 2024-01-18 |
| Rapid (6.0) (K233512) | Ischemaview, Inc. | 2024-01-16 |
| DASI Dimensions (V1.0) (K231324) | Dasi Simulations | 2024-01-08 |
| VEA Align (K231917) | Eos Imaging | 2024-01-05 |
| TumorSight Viz (K231130) | SimBioSys, Inc. | 2023-12-26 |
| iQ-solutions (K231929) | Sydney Neuroimaging Analysis Centre Pty, Ltd. | 2023-12-18 |
| QP-Brain® (K232231) | Quibim S.L. | 2023-12-13 |
| Transpara Density 1.0.0 (K232096) | Screenpoint Medical B.V. | 2023-12-11 |
| Bonelogic (K223757) | Disior, Ltd. | 2023-12-08 |
| Ceevra Reveal 3+ (K233568) | Ceevra, Inc. | 2023-12-05 |
| Adravision Perio (K232440) | Adra Corporation | 2023-12-05 |
| Syngo Carbon Clinicals (K232856) | Siemens Healthcare GmbH | 2023-12-01 |
| syngo.via MI Workflows; Scenium; syngo MBF (K232000) | Siemens Medical Solutions USA, Inc. | 2023-11-28 |
| AI Platform (AIP001) (K232501) | Exo, Inc. | 2023-11-17 |
| Axial3D Insight (K232841) | Axial Medical Printing Limited | 2023-11-15 |
| BriefCase-Quantification (K232083) | Aidoc Medical , Ltd. | 2023-11-13 |
| Clarius Bladder AI (K232257) | Clarius Mobile Health Corp. | 2023-11-13 |
| BriefCase-Quantification (K230534) | Aidoc Medical , Ltd. | 2023-11-08 |
| aprevo® Digital Segmentation (K231955) | Carlsmed, Inc. | 2023-11-03 |
| AI-Rad Companion Brain MR (K232305) | Siemens Medical Solutions U.S.A. | 2023-10-23 |
| Sonix Health (K230209) | Ontact Health Co., Ltd. | 2023-10-20 |
| cmAngio® V1.0 (K232367) | Curemetrix, Inc. | 2023-10-05 |
| VUNO Med-DeepBrain (K231398) | Vuno, Inc. | 2023-10-04 |
| HipCheck (K230045) | Stryker Corp. | 2023-09-29 |
| qXR-CTR (K231149) | Qure.Ai Technologies | 2023-09-22 |
| DeepXray (K223621) | Alpha Intelligence Manifolds, Inc. | 2023-09-08 |
| ANDI (K230913) | Imeka Solutions, Inc. | 2023-07-25 |
| OptimMRI (K230150) | Rebrain, Sas | 2023-07-21 |
| uOmnispace (K230039) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-20 |
| Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) (K223106) | Brainlab AG | 2023-07-14 |
| Ez3D-i /E3 (K231757) | Ewoosoft Co., Ltd. | 2023-07-14 |
| Spine CAMP™ (1.1) (K231668) | Medical Metrics, Inc. | 2023-07-07 |
| Axial3D Insight (K222745) | Axial Medical Printing Limited | 2023-07-03 |
| Bladder AI (AIBV01) (K230497) | Exo, Inc. | 2023-06-22 |
| IB Lab LAMA (K223646) | Ib Lab GmbH | 2023-06-16 |
| DeepCatch (K223556) | Medical IP Co., Ltd. | 2023-06-16 |
| FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855) | Feops NV | 2023-06-06 |
| SIS System (K230977) | Surgical Information Sciences, Inc. | 2023-05-02 |
| Ceevra Reveal 3 (K222676) | Ceevra, Inc. | 2023-04-25 |
| ViewFinder Software Version 1.1 (K223501) | Elaitra, Ltd. | 2023-04-21 |
| CerebralGo Plus (K213986) | Yukun (Beijing) Technology Co., Ltd. | 2023-04-13 |
| Formus Hip (K213272) | Formus Labs, Ltd. | 2023-03-31 |
| RadioLens v1.0 (K222174) | Synapsica | 2023-03-28 |
| MPXA-2000 (K222036) | Medipixel, Inc. | 2023-03-22 |
| BoneMRI v1.6 (K230197) | Mriguidance B.V. | 2023-02-22 |
| Videa Perio Assist (K223296) | Videahealth, Inc. | 2023-02-06 |
| Rapid RV/LV (K223396) | Ischemaview, Inc. | 2023-02-01 |
| LVivo IQS (K222970) | Dia Imaging Analysis, Ltd. | 2023-02-01 |
| Clarius AI (K222406) | Clarius Mobile Health Corp. | 2023-01-23 |
| AVIEW (K214036) | Coreline Soft Co., Ltd. | 2022-12-23 |
| Saige-Density (K222275) | DeepHealth, Inc. | 2022-12-16 |
| BrainInsight (K223268) | Hyperfine, Inc. | 2022-12-16 |
| SIS System (Version 5.6.0) (K223032) | Surgical Information Sciences, Inc. | 2022-11-21 |
| BoneMRI v1.4 (K221762) | Mrlguidance B.V. | 2022-11-16 |
| Syngo Dynamics (Version VA40F) (K222428) | Siemens Medical Solutions USA, Inc. | 2022-11-14 |
| Spine CAMP™ (K221632) | Medical Metrics, Inc. | 2022-10-18 |
| QIR Suite (K211611) | Casis Cardiac Simulation & Imaging Software | 2022-09-30 |
| NS-HGlio (K221738) | Neosoma, Inc. | 2022-09-27 |
| Viz RV/LV (K221100) | Viz. Ai, Inc. | 2022-08-29 |
| MI View&GO (K222172) | Siemens Medical Solutions USA, Inc. | 2022-08-19 |
| ClearPoint Maestro Brain Model (K213645) | ClearPoint Neuro, Inc. | 2022-08-08 |
| Customize (K221432) | 3D-Side S.A. | 2022-08-03 |
| cvi42 Auto Imaging Software Application (K213998) | Circle Cardiovascular Imaging, Inc. | 2022-07-28 |
| EchoPAC Software Only, EchoPAC Plug-in (K220940) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-22 |
| Libby Echo:Prio (K220956) | Dyad Medical, Inc. | 2022-07-20 |
| BrainInsight (K220815) | Hyperfine, Inc. | 2022-07-19 |
| CoLumbo (K220497) | Smart Soft Healthcare AD | 2022-06-23 |
| AI-Rad Companion Brain MR (K213706) | Siemens Healthcare GmbH | 2022-04-15 |
| EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624) | Ever Fortune.Ai, Co., Ltd. | 2022-04-04 |
| Customize (K213779) | 3D-Side S.A. | 2022-03-16 |
| Arterys MICA (K203744) | Arterys, Inc. | 2022-03-14 |
| Caption Interpretation Automated Ejection Fraction Software (K210747) | Caption Health | 2022-01-19 |
| Follicle Clarity (K212012) | Cycle Clarity | 2022-01-19 |
| TOMTEC-ARENA (K213544) | Tomtec Imaging Systems GmbH | 2022-01-06 |
| BoneMRI (K202404) | Mriguidance B.V. | 2021-12-22 |
| qXR-BT (K212690) | Qure.Ai Technologies | 2021-12-21 |
| EchoGo Core (2.0) (K213275) | Ultromics Limited | 2021-12-20 |
| LVivo Seamless (K212466) | Dia Imaging Analysis, Ltd. | 2021-12-09 |
| OnQ Neuro (K210831) | Cortechs Labs, Inc. | 2021-11-19 |
| Critical Care Suite with Endotracheal Tube Positing AI algorithm (K211161) | Ge Medical Systems, LLC | 2021-10-29 |
| ClariSIGMAM (K203785) | Claripi, Inc. | 2021-09-10 |
| AmCAD-UT (K203555) | Amcad Biomed Corporation | 2021-09-08 |
| breastscape v1.0 (K211431) | Olea Medical | 2021-08-02 |
| qER-Quant (K211222) | Qure.Ai Technologies | 2021-07-30 |
| Us2.v1 (K210791) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2021-07-27 |
| Change Healthcare Anatomical AI (K210719) | Change Healthcare Canada Company | 2021-07-20 |
| PowerLook Density Assessment V4.0 (K211506) | Icad, Inc. | 2021-07-12 |
Track QIH automatically
Every clearance here is in the API, with alerts when new ones post.