305 devices · 209 companies · 2019 to 2026
Product code QIH: Automated Radiological Image Processing Software
305 devices under product code QIH, 2019 to 2026, from 209 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (296 of 305 here), the regulation, and MAUDE report counts by product code.
Automated Radiological Image Processing Software. 21 CFR 892.2050, Class II. To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code. MAUDE held 10 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
By year under product code QIH
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.12
- DiA Imaging Analysis Ltd.10
- Shanghai United Imaging Healthcare Co., Ltd.6
- Siemens Healthcare GmbH5
- Overjet, Inc.5
- Clarius Mobile Health Corp.5
- Neurophet., Inc.4
- Peek Health, S.A.4
- Eos Imaging4
- iSchemaView, Inc.4
- Coreline Soft Co., Ltd.4
- Aidoc Medical, Ltd.4
- Qure.ai Technologies4
- Mighty Oak Medical3
- Imeka Solutions, Inc.3
- DeepHealth, Inc.3
- Subtle Medical, Inc.3
- Smart Soft Healthcare AD3
- Circle Cardiovascular Imaging, Inc.3
- Terarecon,Inc.3
- Disior Ltd3
- Axial Medical Printing Limited3
- Arterys, Inc.3
- SimBioSys, Inc.3
- Viz.ai, Inc.3
- Ceevra, Inc.3
- Exo Inc3
- Surgical Information Sciences, Inc.3
- MRIguidance B.V3
- Adas3D Medical S.L.2
- FUJIFILM Healthcare Americas Corporation2
- Crescom Co., Ltd.2
- Siemens Healthineers AG2
- Medicrea International S.A.S. (Medtronic)2
- Fujifilm Corporation2
- Ge Medical Systems, LLC2
- Relu BV2
- ViTAA Medical Solutions, Inc.2
- Airs Medical, Inc.2
- Philips Medical Systems Nederland B.V.2
- Beijing Infervision Healthcare Medical Technology Co., Ltd.2
- Ligence Uab2
- Exo Imaging2
- Neosoma, Inc.2
- Intuitive Surgical, Inc.2
- Galileo CDS, Inc2
- Therapixel2
- Artrya Limited2
- GE Medical Systems Ultrasound and Primary Care Diagnostics2
- PIUR Imaging GmbH2
- Brainlab AG2
- BrightHeart2
- Ewoosoft Co., Ltd2
- Pearl, Inc.2
- CureMetrix, Inc.2
- Ezra AI, Inc.2
- Ontact Health Co., Ltd2
- CorTechs Labs, Inc.2
- Rebrain, SAS2
- Ever Fortune.AI Co., Ltd.2
- Genesis Software Innovations2
- Eko.ai Pte. Ltd d/b/a Us2.ai2
- Medical Metrics, Inc.2
- Hyperfine, Inc.2
- 3D-Side SA2
- Caption Health2
- Philips Healthcare2
The newest 150 devices
305 devices under product code QIH is more than one table should carry. The 150 newest decisions are below; every device has a page of its own, reached through the product-code and year lists above.
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Auto-SegK253628 · 510(k) | Agada Medical, Ltd. | Radiology | database entry | |
| ADAS 3DK253969 · 510(k) | Adas3D Medical S.L. | Radiology | database entry | |
| syngo.CT Coronary CockpitK253786 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| CMN Capillary Function with Oncology Virtual ExpK260316 · 510(k) | Cercare Medical A/S | Radiology | database entry | |
| Synapse PACSK261713 · 510(k) | FUJIFILM Healthcare Americas Corporation | Radiology | database entry | |
| MediAI-OAK253172 · 510(k) | Crescom Co., Ltd. | Radiology | database entry | |
| LungMapsK253690 · 510(k) | Siemens Healthineers AG | Radiology | database entry | |
| WatchMate SoftwareK260300 · 510(k) | Anumana, Inc. | Radiology | database entry | |
| Brainomix 360 HyperdensityK260406 · 510(k) | Brainomix Limited | Radiology | database entry | |
| Acorn 3D SoftwareK260322 · 510(k) | Mighty Oak Medical | Radiology | database entry | |
| DEEPVESSEL PlaqueK260497 · 510(k) | Keya Medical Technology Co., Ltd. | Radiology | database entry | |
| OrthoGrid Hip AI 4.0K260077 · 510(k) | OrthoGrid Systems, Inc. | Radiology | database entry | |
| ANDI 2.2K261405 · 510(k) | Imeka Solutions, Inc. | Radiology | database entry | |
| Vitrea CT Transcatheter Aortic Valve ReplacementK260324 · 510(k) | Canon Medical Informatics, Inc. | Radiology | database entry | |
| BACK254131 · 510(k) | DeepHealth, Inc. | Radiology | database entry | |
| MSK GoK260234 · 510(k) | Smart Alfa Teknoloji San. Ve Tic. A.S. | Radiology | database entry | |
| Neurophet SCALE PETK252563 · 510(k) | Neurophet., Inc. | Radiology | database entry | |
| SubtleHD-CTK254120 · 510(k) | Subtle Medical, Inc. | Radiology | database entry | |
| Neurophet AQUAK261273 · 510(k) | Neurophet., Inc. | Radiology | database entry | |
| UNiD Spine AnalyzerK261289 · 510(k) | Medicrea International S.A.S. (Medtronic) | Radiology | database entry | |
| MorphK260032 · 510(k) | BeauBrain Healthcare, Inc. | Radiology | database entry | |
| Synapse 3D Base ToolsK254189 · 510(k) | Fujifilm Corporation | Radiology | database entry | |
| syngo Application SoftwareK254184 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| DS Core CBCT AnatomyK260785 · 510(k) | Dentsply Sirona | Radiology | database entry | |
| uOmnispace.MRK253077 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| FolliscanK252332 · 510(k) | Mim Fertility | Radiology | database entry | |
| Critical Care Suite with Enteric Tube PositioninK253502 · 510(k) | Ge Medical Systems, LLC | Radiology | database entry | |
| Relu CloudK252708 · 510(k) | Relu BV | Radiology | database entry | |
| syngo DynamicsK253689 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| Overjet Iris Intelligent Imaging SystemK253930 · 510(k) | Overjet, Inc. | Radiology | database entry | |
| CoLumbo C-SpineK254015 · 510(k) | Smart Soft Healthcare AD | Radiology | database entry | |
| AiORTA - Plan v2.0K254207 · 510(k) | ViTAA Medical Solutions, Inc. | Radiology | database entry | |
| SwiftMRK253775 · 510(k) | Airs Medical, Inc. | Radiology | database entry | |
| EchoNavigator R5.0K253614 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| Data Analysis Facilitation SuiteK253944 · 510(k) | Voronoi Health Analytics Incorporated | Radiology | database entry | |
| InferCare RECISTK252261 · 510(k) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | database entry | |
| VELYS Hip NavigationK253551 · 510(k) | Depuy Ireland UC | Radiology | database entry | |
| CEPHX3DK252538 · 510(k) | Orca Dental AI , Ltd. | Radiology | database entry | |
| Clarius Ejection Fraction AIK253593 · 510(k) | Clarius Mobile Health Corp. | Radiology | database entry | |
| Ligence HeartK253535 · 510(k) | Ligence Uab | Radiology | database entry | |
| AI Platform 2.2K260217 · 510(k) | Exo Imaging | Radiology | database entry | |
| AI4CMR v2.0K252084 · 510(k) | Ai4medimaging Medical Solutions S.A. | Radiology | database entry | |
| MI View&GOK254016 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Surgical Reality ViewerK252091 · 510(k) | Medicalvr B.V. | Radiology | database entry | |
| Neurophet AQUA AD PlusK252496 · 510(k) | Neurophet., Inc. | Radiology | database entry | |
| AV VascularK253735 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| AI-Rad Companion Brain MRK253057 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| Imagine Enterprise SuiteK252634 · 510(k) | Softlink International Private Limited | Radiology | database entry | |
| TruSPECT Processing StationK253532 · 510(k) | Spectrum Dynamics Medical, Ltd. | Radiology | database entry | |
| PeekMed webK252856 · 510(k) | Peek Health, S.A. | Radiology | database entry | |
| AlzevitaK252670 · 510(k) | TOPIA MEDTECH LIMITED | Radiology | database entry | |
| AI-CVDK252029 · 510(k) | HeartLung Corporation | Radiology | database entry | |
| MediAI-BAK250914 · 510(k) | Crescom Co., Ltd. | Radiology | database entry | |
| PVAD IQ SoftwareK252235 · 510(k) | Ultrasight , Ltd. | Radiology | database entry | |
| Neosoma Brain MetsK252922 · 510(k) | Neosoma, Inc. | Radiology | database entry | |
| IRISegK251763 · 510(k) | Intuitive Surgical, Inc. | Radiology | database entry | |
| Overjet CBCT AssistK251514 · 510(k) | Overjet, Inc. | Radiology | database entry | |
| Acorn 3D SoftwareK252103 · 510(k) | Mighty Oak Medical | Radiology | database entry | |
| AutoDensityK251078 · 510(k) | Eos Imaging | Radiology | database entry | |
| PeekMed webK252452 · 510(k) | Peek Health, S.A. | Radiology | database entry | |
| 3mensio WorkstationK250330 · 510(k) | Pie Medical Imaging BV | Radiology | database entry | |
| AiORTA - PlanK250337 · 510(k) | ViTAA Medical Solutions, Inc. | Radiology | database entry | |
| cvi42 Coronary Plaque Software ApplicationK251027 · 510(k) | Circle Cardiovascular Imaging, Inc. | Radiology | database entry | |
| Syngo Carbon ClinicalsK251059 · 510(k) | Siemens Healthineers AG | Radiology | database entry | |
| TeraRecon Cardiovascular.Calcification.CTK250288 · 510(k) | Terarecon,Inc. | Radiology | database entry | |
| ANDI 2.0K252298 · 510(k) | Imeka Solutions, Inc. | Radiology | database entry | |
| brAIn Shoulder PositioningK252665 · 510(k) | Avatar Medical | Radiology | database entry | |
| AIAS CephalonK252214 · 510(k) | Metamorphosis GmbH | Radiology | database entry | |
| BlineSlideK252007 · 510(k) | Deep Breathe, Inc. | Radiology | database entry | |
| SMART PCFDK250023 · 510(k) | Disior Ltd | Radiology | database entry | |
| Ligence HeartK252105 · 510(k) | Ligence, UAB | Radiology | database entry | |
| Brain WMHK251527 · 510(k) | Quantib BV | Radiology | database entry | |
| SwiftSight-BrainK251483 · 510(k) | AIRS Medical Inc. | Radiology | database entry | |
| Rapid Aortic MeasurementsK251987 · 510(k) | iSchemaView, Inc. | Radiology | database entry | |
| Axial3D InsightK250369 · 510(k) | Axial Medical Printing Limited | Radiology | database entry | |
| InferOperate SuiteK250237 · 510(k) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | database entry | |
| AngioWaveNetK244002 · 510(k) | Angiowave Imaging, Inc. | Radiology | database entry | |
| Segmentron ViewerK251072 · 510(k) | DGNCT, LLC | Radiology | database entry | |
| Careverse CoronaryDocK251656 · 510(k) | Careverse Technology Pte. Ltd. | Radiology | database entry | |
| Tempus PixelK252539 · 510(k) | Arterys, Inc. | Radiology | database entry | |
| PRAEVAorta2K243859 · 510(k) | Nurea | Radiology | database entry | |
| GBrain MRIK252362 · 510(k) | Galileo CDS, Inc | Radiology | database entry | |
| MammoScreen BDK243685 · 510(k) | Therapixel | Radiology | database entry | |
| Salix Coronary PlaqueK251837 · 510(k) | Artrya Limited | Radiology | database entry | |
| VEA AlignK251747 · 510(k) | EOS imaging | Radiology | database entry | |
| DS Core DiagnosisK250755 · 510(k) | Dentsply Sirona Inc. | Radiology | database entry | |
| UNiD Spine AnalyzerK251629 · 510(k) | Medicrea International S.A.S. (Medtronic) | Radiology | database entry | |
| Voxel DosimetryK243919 · 510(k) | Hermes Medical Solutions AB | Radiology | database entry | |
| EchoPAC Software Only / EchoPAC Plug-inK251342 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | database entry | |
| PeekMed webK251096 · 510(k) | Peek Health, S.A. | Radiology | database entry | |
| TumorSight VizK251766 · 510(k) | SimBioSys, Inc. | Radiology | database entry | |
| syngo.via MI WorkflowsK251528 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Bunkerhill Abdominal Aortic QuantificationK243779 · 510(k) | BunkerHill Health | Radiology | database entry | |
| PIUR tUS insideK250484 · 510(k) | PIUR Imaging GmbH | Radiology | database entry | |
| Synapse PACSK243647 · 510(k) | FUJIFILM Healthcare Americas Corporation | Radiology | database entry | |
| EchoConfidenceK250670 · 510(k) | Mycardium AI Limited | Radiology | database entry | |
| Brainlab ElementsK243633 · 510(k) | Brainlab AG | Radiology | database entry | |
| Viz Subdural+, Viz SUBDURAL PLUSK250354 · 510(k) | Viz.ai, Inc. | Radiology | database entry | |
| Cirrus Resting State fMRI SoftwareK251009 · 510(k) | Sora Neuroscience, Inc. | Radiology | database entry | |
| BrightHeart View ClassifierK251456 · 510(k) | BrightHeart | Radiology | database entry | |
| TraumaCad NeoK243810 · 510(k) | Brainlab Ltd. | Radiology | database entry | |
| AudaxCeph Cephalogram Analysis SoftwareK243005 · 510(k) | Audax d.o.o. | Radiology | database entry | |
| Opulus Lymphoma PrecisionK243863 · 510(k) | Roche Molecular Systems, Inc. | Radiology | database entry | |
| CoLumboXK250367 · 510(k) | Smart Soft Healthcare AD | Radiology | database entry | |
| Rapid MLSK243378 · 510(k) | iSchemaview Inc. | Radiology | database entry | |
| Clever OneK250005 · 510(k) | Ewoosoft Co., Ltd | Radiology | database entry | |
| Second Opinion 3DK243989 · 510(k) | Pearl, Inc. | Radiology | database entry | |
| Synapse 3D Base ToolsK243762 · 510(k) | FUJIFILM Corporation | Radiology | database entry | |
| Medical Image Post-processing SoftwareK242624 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Second Opinion BLEK243230 · 510(k) | Pearl Inc. | Radiology | database entry | |
| Clarius Median Nerve AIK250226 · 510(k) | Clarius Mobile Health Corp. | Radiology | database entry | |
| BrightHeart View ClassifierK243684 · 510(k) | BrightHeart | Radiology | database entry | |
| UltraExtend NX CUW-U001S V2.0 Ultrasound Image AK250328 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| LARALABK242500 · 510(k) | LARALAB GmbH | Radiology | database entry | |
| Clarius Prostate AIK243853 · 510(k) | Clarius Mobile Health Corp. | Radiology | database entry | |
| GBrain MRIK250416 · 510(k) | Galileo CDS, Inc | Radiology | database entry | |
| cmAngioK250754 · 510(k) | CureMetrix, Inc. | Radiology | database entry | |
| DeepFoqusK241982 · 510(k) | Foqus Technologies Inc. | Radiology | database entry | |
| syngo DynamicsK242551 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| Hi-D Imaging 4TAVRK241984 · 510(k) | Hi-D Imaging AG | Radiology | database entry | |
| TribusConnectK242166 · 510(k) | TribusMed Beheer BV | Radiology | database entry | |
| Salix CentralK243038 · 510(k) | Artrya Limited | Radiology | database entry | |
| Vent Creativity Knee v1.0K241961 · 510(k) | Vent Creativity | Radiology | database entry | |
| AVIEWK243689 · 510(k) | Coreline Soft Co., Ltd. | Radiology | database entry | |
| PeekMed webK250042 · 510(k) | Peek Health, S.A. | Radiology | database entry | |
| LVivo Software ApplicationK243862 · 510(k) | DiA Imaging Analysis Ltd. | Radiology | database entry | |
| Cleerly LABSK242338 · 510(k) | Cleerly, Inc. | Radiology | database entry | |
| LVivo SeamlessK243331 · 510(k) | DiA Imaging Analysis Ltd. | Radiology | database entry | |
| Ceevra Reveal 3+K243933 · 510(k) | Ceevra, Inc. | Radiology | database entry | |
| LVivo Software ApplicationK243235 · 510(k) | DiA Imaging Analysis Ltd. | Radiology | database entry | |
| MyomicsK241922 · 510(k) | Phantomics Inc. | Radiology | database entry | |
| Ventripoint Medical System PlusK241222 · 510(k) | Ventripoint Diagnostics Ltd. | Radiology | database entry | |
| ScanDiags Ortho L-Spine MR-QK242607 · 510(k) | ScanDiags AG | Radiology | database entry | |
| AVIEW CACK243696 · 510(k) | Coreline Soft Co., Ltd. | Radiology | database entry | |
| SubtleHDK243250 · 510(k) | Subtle Medical, Inc. | Radiology | database entry | |
| Ultrasound WorkspaceK241659 · 510(k) | Philips Ultrasound LLC | Radiology | database entry | |
| BoneMetricsK241593 · 510(k) | Gleamer SAS | Radiology | database entry | |
| TeraRecon Aorta.CTK243158 · 510(k) | TeraRecon, Inc. | Radiology | database entry | |
| Rapid Neuro3DK243350 · 510(k) | iSchemaView, Inc. | Radiology | database entry | |
| Ortho AIK241696 · 510(k) | Ortho AI LLC | Radiology | database entry | |
| Ezra FlashK242334 · 510(k) | Ezra AI, Inc. | Radiology | database entry | |
| Saige-DensityK243705 · 510(k) | DeepHealth, Inc | Radiology | database entry | |
| OrthoNext Platform SystemK242270 · 510(k) | Orthofix Srl | Radiology | database entry | |
| MSKaiK240793 · 510(k) | MSKai | Radiology | database entry | |
| IRISegK242461 · 510(k) | Intuitive Surgical Inc. | Radiology | database entry | |
| DrAid for Liver SegmentationK241543 · 510(k) | VinBrain Joint Stock Company | Radiology | database entry | |
| CDM InsightsK240680 · 510(k) | Oxford Brain Diagnostics Ltd | Radiology | database entry | |
| Sonix HealthK240645 · 510(k) | Ontact Health Co., Ltd | Radiology | database entry | |
| BriefCase-QuantificationK242203 · 510(k) | Aidoc Medical, Ltd. | Radiology | database entry | |
| Strain AIK242359 · 510(k) | Exo Inc | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.