235 devices · 182 companies · 2024
AI-enabled medical devices FDA authorized in 2024
235 devices authorized in 2024, 2024, from 182 companies across 60 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (227 of 235 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2024
- QIH · Automated Radiological Image Processing Software63
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic22
- JAK · System, X-Ray, Tomography, Computed14
- LNH · System, Nuclear Magnetic Resonance Imaging13
- QAS · Radiological Computer-Assisted Triage And Notification Software12
- LLZ · System, Image Processing, Radiological10
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer7
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions6
- QKB · Radiological Image Processing Software For Radiation Therapy6
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer6
- KPS · System, Tomography, Computed, Emission5
- OMB · Automatic Event Detection Software For Full-Montage Electroencephalograph5
- QNP · Gastrointesinal Lesion Software Detection System5
- IYO · System, Imaging, Pulsed Echo, Ultrasonic3
- OLO · Orthopedic Stereotaxic Instrument3
- QWO · Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.2
- DQK · Computer, Diagnostic, Programmable2
- OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph2
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture2
- QZW · Over-The-Counter Device To Assess Risk Of Sleep Apnea2
- MYN · Analyzer, Medical Image2
- MNR · Ventilatory Effort Recorder2
- QNL · Medium-Term Adjunctive Predictive Cardiovascular Indicator2
- KPR · System, X-Ray, Stationary2
- MUJ · System, Planning, Radiation Therapy Treatment2
- HAW · Neurological Stereotaxic Instrument1
- QME · Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1
- SDJ · Adjunctive Cardiac Amyloidosis Status Indicator1
- SBF · Orthopedic Augmented Reality1
- QUO · Adjunctive Heart Failure Status Indicator1
- OTE · Digital Breast Tomosynthesis1
- PZP · Fluid Jet Removal System1
- QHE · Shoulder Arthroplasty Implantation System1
- QMS · Adjunctive Open Loop Fluid Therapy Recommender1
- PHZ · Abnormal Breath Sound Device1
- OWB · Interventional Fluoroscopic X-Ray System1
- SBQ · Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software1
- DPS · Electrocardiograph1
- MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1
- OUO · Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance1
- SBC · Dental Image Analyzer1
- PNN · Orthodontic Software1
- SAX · Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device1
- MWJ · Electrocardiograph, Ambulatory (Without Analysis)1
- LKM · Counter, Urine Particle1
- IYE · Accelerator, Linear, Medical1
- PIB · Diabetic Retinopathy Detection Device1
- QTZ · Radiological Image Processing Software For Ablation Therapy Planning And Evaluation1
- SAO · Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density1
- SAT · Pulmonary Hypertension Machine Learning-Based Notification Software1
- SAR · Adjunctive Hemodynamic Indicator With Decision Point For Military Use1
- LEL · Device, Sleep Assessment1
- SAK · Software Device To Aid In The Prediction Or Diagnosis Of Sepsis1
- QYE · Reduced Ejection Fraction Machine Learning-Based Notification Software1
- QRY · Dental Navigation System1
- POS · Physiological Signal Based Seizure Monitoring System1
- QYV · Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm1
- QZS · Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer1
- QWT · Prognostic Assessment Software Of Mild Cognitive Impairment1
- PBZ · Image Processing Device For Estimation Of External Blood Loss1
Panels
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.12
- Shanghai United Imaging Healthcare Co.,Ltd.9
- Canon Medical Systems Corporation6
- Philips Ultrasound LLC5
- Aidoc Medical, Ltd.5
- Samsung Medison Co., Ltd.5
- Avicenna.AI4
- Overjet Inc4
- GE Medical Systems Ultrasound and Primary care Diagnostics3
- DeepHealth, Inc3
- Ever Fortune.AI, Co., Ltd.3
- Imbio, Inc.2
- Beacon Biosignals, Inc.2
- Ultromics Limited2
- Epitel, Inc2
- DiA Imaging Analysis Ltd.2
- Therapixel2
- JLK, Inc.2
- Shanghai United Imaging Intelligence Co., Ltd.2
- Subtle Medical, Inc.2
- Nano-X AI Ltd.2
- Cosmo Artificial Intelligence - AI Ltd2
- Iterative Scopes, Inc.2
- Disior Ltd2
- EOS imaging2
- AliveCor, Inc.2
- Siemens Healthcare GmbH2
- iSchemaView, Inc.2
The newest 150 devices
235 devices authorized in 2024 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 | Product code | FDA |
|---|---|---|---|---|---|
| FLASH EVD SystemK242480 · 510(k) | 7D Surgical ULC | Neurology | HAW | database entry | |
| Aquilion ONEK242403 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Voluson Expert 18K242168 · 510(k) | GE Medical Systems Ultrasound and Primary care Diagnostics | Radiology | IYN | database entry | |
| Lightning ViewerK242362 · 510(k) | Nexsys Electronics Inc. dba Medweb | Radiology | LLZ | database entry | |
| Saige-DensityK243705 · 510(k) | DeepHealth, Inc | Radiology | QIH | database entry | |
| OrthoNext Platform SystemK242270 · 510(k) | Orthofix Srl | Radiology | QIH | database entry | |
| IQ-UIPK242467 · 510(k) | Imbio, Inc. | Radiology | QWO | database entry | |
| Saige-DxK243688 · 510(k) | DeepHealth, Inc. | Radiology | QDQ | database entry | |
| MSKaiK240793 · 510(k) | MSKai | Radiology | QIH | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK242020 · 510(k) | Philips Ultrasound LLC | Radiology | IYN | database entry | |
| uMI PanvivoK243538 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | KPS | database entry | |
| BriefCase-TriageK243548 · 510(k) | Aidoc Medical, Ltd. | Radiology | QFM | database entry | |
| IRISegK242461 · 510(k) | Intuitive Surgical Inc. | Radiology | QIH | database entry | |
| V5 Diagnostic Ultrasound System, H5 Diagnostic UK242511 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| AutoContourK242729 · 510(k) | Radformation, Inc. | Radiology | QKB | database entry | |
| DrAid for Liver SegmentationK241543 · 510(k) | VinBrain Joint Stock Company | Radiology | QIH | database entry | |
| EFAI Neurosuite CT Midline Shift Assessment SystK241923 · 510(k) | Ever Fortune.AI, Co., Ltd. | Radiology | QAS | database entry | |
| CDM InsightsK240680 · 510(k) | Oxford Brain Diagnostics Ltd | Radiology | QIH | database entry | |
| PeekMed webK240926 · 510(k) | Peek Health, S.A. | Radiology | LLZ | database entry | |
| DeepRhythmAIK241197 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | DQK | database entry | |
| ClearRead CT CACK242188 · 510(k) | Riverain Technologies, Inc. | Radiology | JAK | database entry | |
| Sonix HealthK240645 · 510(k) | Ontact Health Co., Ltd | Radiology | QIH | database entry | |
| HERA W10 Diagnostic Ultrasound SystemK242444 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| NeuroMatchK241390 · 510(k) | LVIS Corporation | Neurology | OMB | database entry | |
| TransparaK241831 · 510(k) | ScreenPoint Medical B.V. | Radiology | QDQ | database entry | |
| BriefCase-QuantificationK242203 · 510(k) | Aidoc Medical, Ltd. | Radiology | QIH | database entry | |
| Dreem 3SK242094 · 510(k) | Beacon Biosignals, Inc. | Neurology | OLZ | database entry | |
| Strain AIK242359 · 510(k) | Exo Inc | Radiology | QIH | database entry | |
| ACUSON Sequoia Diagnostic Ultrasound SystemK242523 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | IYN | database entry | |
| Informed Vital Core ApplicationK241633 · 510(k) | Mindset Medical, Inc. | Cardiovascular | QME | database entry | |
| Saige-DxK241747 · 510(k) | DeepHealth, Inc | Radiology | QDQ | database entry | |
| Koios DSK242130 · 510(k) | Koios Medical, Inc. | Radiology | POK | database entry | |
| VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TrK241439 · 510(k) | Vuno Inc. | Radiology | QFM | database entry | |
| The 5000 Compact Series Ultrasound SystemsK242800 · 510(k) | Philips Ultrasound LLC | Radiology | IYN | database entry | |
| 1CMR ProK242062 · 510(k) | Mycardium AI Limited | Radiology | LLZ | database entry | |
| EchoGo AmyloidosisK240860 · 510(k) | Ultromics Limited | Cardiovascular | SDJ | database entry | |
| Fetal EchoScanK242342 · 510(k) | BrightHeart | Radiology | POK | database entry | |
| ProFound DetectionK240417 · 510(k) | iCAD, Inc. | Radiology | QDQ | database entry | |
| NeuroICHK241719 · 510(k) | Neurocareai Inc. | Radiology | QAS | database entry | |
| icobrain ariaK240712 · 510(k) | icometrix NV | Radiology | QBS | database entry | |
| TeraRecon Cardiac.Chambers.MRK241312 · 510(k) | TeraRecon,Inc. | Radiology | QIH | database entry | |
| RemedyLogic AI MRI Lumbar Spine ReaderK241108 · 510(k) | Remedy Logic Inc. | Radiology | QIH | database entry | |
| TumorSight VizK243189 · 510(k) | SimBioSys, Inc. | Radiology | QIH | database entry | |
| Neurophet AQUAK242215 · 510(k) | Neurophet, Inc. | Radiology | QIH | database entry | |
| nordicMEDiVAK243209 · 510(k) | NordicNeurolab AS | Radiology | LLZ | database entry | |
| Contour+K241490 · 510(k) | MVision AI Oy | Radiology | QKB | database entry | |
| BriefCase-TriageK242837 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| SIGNA MAGNUSK241242 · 510(k) | GE Medical Systems, LLC | Radiology | LNH | database entry | |
| REMI-AI Rapid Detection ModuleK240408 · 510(k) | Epitel, Inc | Neurology | OMB | database entry | |
| xvision Spine SystemK241481 · 510(k) | Augmedics Ltd. | Neurology | SBF | database entry | |
| cvi42 Software ApplicationK242781 · 510(k) | Circle Cardiovascular Imaging Inc. | Radiology | QIH | database entry | |
| HERA Z20, R20, HERA Z30, R30 Diagnostic UltrasouK241971 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| EchoMeasureK241430 · 510(k) | iCardio.ai | Radiology | QIH | database entry | |
| Limbus ContourK241837 · 510(k) | Limbus AI Inc. | Radiology | QKB | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK240980 · 510(k) | Philips Ultrasound LLC | Radiology | IYN | database entry | |
| SpineUs SystemK241029 · 510(k) | Verdure Imaging | Radiology | IYO | database entry | |
| Lunit INSIGHT DBT v1.1K242652 · 510(k) | Lunit Inc. | Radiology | QDQ | database entry | |
| EchoSolv ASK241245 · 510(k) | Echo IQ Ltd | Radiology | POK | database entry | |
| LVivo Software ApplicationK240553 · 510(k) | DiA Imaging Analysis Ltd. | Radiology | QIH | database entry | |
| Versana PremierK242005 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| MammoScreen BDK241561 · 510(k) | Therapixel | Radiology | QIH | database entry | |
| LungVisionK240943 · 510(k) | BodyVision Medical Ltd. | Radiology | QIH | database entry | |
| MuscleViewK241331 · 510(k) | Springbok, Inc. | Radiology | LNH | database entry | |
| encevisK240993 · 510(k) | AIT Austrian Institute of Technology GmbH | Neurology | OMB | database entry | |
| CACK240369 · 510(k) | BunkerHill Health | Radiology | JAK | database entry | |
| JBS-LVOK241480 · 510(k) | JLK, Inc. | Radiology | QAS | database entry | |
| uAI Easy Triage ICHK242292 · 510(k) | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | QAS | database entry | |
| EchoGo Heart FailureK240013 · 510(k) | Ultromics Limited | Cardiovascular | QUO | database entry | |
| MAMMOMAT B.brilliant with Tomosynthesis OptionP140011/S008 · PMA | SIEMENS MEDICAL SOLUTIONS USA, INC. | Radiology | OTE | database entry | |
| PIUR tUS InfinityK240036 · 510(k) | PIUR Imaging GmbH | Radiology | QIH | database entry | |
| Sleep Apnea Notification FeatureK240929 · 510(k) | Apple Inc. | Anesthesiology | QZW | database entry | |
| ConstellationK241280 · 510(k) | Q Bio, Inc. | Radiology | QIH | database entry | |
| CINA-CSpineK240942 · 510(k) | Avicenna.AI | Radiology | QAS | database entry | |
| Aplio i900/i800/i700 Diagnostic Ultrasound SysteK241582 · 510(k) | Canon Medical Systems Corporation | Radiology | IYN | database entry | |
| FETOLY-HEARTK241380 · 510(k) | Diagnoly | Radiology | IYN | database entry | |
| LumiNE USK240094 · 510(k) | Augmedit B.V. | Radiology | QIH | database entry | |
| ADAS 3DK240791 · 510(k) | Adas3D Medical S.L | Radiology | QIH | database entry | |
| Overjet Image Enhancement AssistK241681 · 510(k) | Overjet Inc | Radiology | QIH | database entry | |
| See-Mode Augmented Reporting Tool, ThyroidK240697 · 510(k) | See-Mode Technologies Pte. Ltd. | Radiology | QDQ | database entry | |
| uAI PortalK240411 · 510(k) | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | QIH | database entry | |
| TRAQinform IQK233998 · 510(k) | AIQ Global, Inc. | Radiology | LLZ | database entry | |
| VelacurK233977 · 510(k) | Sonic Incytes | Radiology | IYO | database entry | |
| Velmeni for DentistsK240003 · 510(k) | Velmeni Inc. | Radiology | MYN | database entry | |
| Imbio PHAK241847 · 510(k) | Imbio, Inc | Radiology | QIH | database entry | |
| uMI PanoramaK241585 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | KPS | database entry | |
| MI View&GOK242300 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| syngo.via MI WorkflowsK242275 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| KosmosK233826 · 510(k) | EchoNous, Inc. | Radiology | IYN | database entry | |
| Overjet Charting AssistK241684 · 510(k) | Overjet, Inc | Radiology | QIH | database entry | |
| NeuroQuantK241098 · 510(k) | CorTechs Labs, Inc. | Radiology | QIH | database entry | |
| AiMIFYK240290 · 510(k) | Subtle Medical, Inc. | Radiology | LLZ | database entry | |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE RecoK241496 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| HYDROS Robotic SystemK240200 · 510(k) | Procept BioRobotics | General and Plastic Surgery | PZP | database entry | |
| HealthCCSngK241440 · 510(k) | Nano-X AI Ltd. | Radiology | JAK | database entry | |
| qCT LN QuantK240740 · 510(k) | Qure.ai Technologies | Radiology | QIH | database entry | |
| HeartKey RhythmK233755 · 510(k) | B-Secur Limited | Cardiovascular | DQK | database entry | |
| uMI PanvivoK241596 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| CoLumboK241211 · 510(k) | Smart Soft Healthcare | Radiology | QIH | database entry | |
| ECHELON Synergy MRI SystemK241429 · 510(k) | FUJIFILM Healthcare Corporation | Radiology | LNH | database entry | |
| OptimMRIK242054 · 510(k) | Rebrain, SAS | Radiology | QIH | database entry | |
| i2ContourK233822 · 510(k) | MRIMath LLC | Radiology | QIH | database entry | |
| Omni LegendK241665 · 510(k) | GE Medical Systems Israel, Functional Imaging | Radiology | KPS | database entry | |
| Precision AI Surgical Planning SystemK233992 · 510(k) | Precision AI Pty Ltd | Orthopedic | QHE | database entry | |
| AI Platform 2.0K240953 · 510(k) | Exo Imaging | Radiology | QIH | database entry | |
| Acumen Assisted Fluid ManagementK233984 · 510(k) | Edwards Lifesciences, LLC | Cardiovascular | QMS | database entry | |
| AISAP Cardio V1.0K234141 · 510(k) | Aisap | Radiology | POK | database entry | |
| CardIQ SuiteK233731 · 510(k) | GE Medical Systems SCS | Radiology | JAK | database entry | |
| MammoScreenK240301 · 510(k) | Therapixel | Radiology | QDQ | database entry | |
| GI Genius Module 100K241887 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | QNP | database entry | |
| CADDIEK240044 · 510(k) | Odin Medical Limited | Gastroenterology-Urology | QNP | database entry | |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUK240704 · 510(k) | Siemens Medical Solutions, USA, Inc. | Radiology | IYN | database entry | |
| RayvolveK240845 · 510(k) | AZmed SAS | Radiology | QBS | database entry | |
| MICSI-RMTK241121 · 510(k) | Microstructure Imaging, Inc. | Radiology | LLZ | database entry | |
| Swoop Portable MR Imaging SystemK240944 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| Huxley SANSA Home Sleep Apnea TestK240285 · 510(k) | Huxley Medical | Anesthesiology | MNR | database entry | |
| Acorn 3D SoftwareK234009 · 510(k) | Mighty Oak Medical | Radiology | QIH | database entry | |
| RUSK233457 · 510(k) | Hutom Inc. | Radiology | QIH | database entry | |
| BriefCase-TriageK241727 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| SubtleSYNTHK241329 · 510(k) | Subtle Medical, Inc. | Radiology | QIH | database entry | |
| SKOUT systemK241508 · 510(k) | Iterative Scopes, Inc. | Gastroenterology-Urology | QNP | database entry | |
| SMART Bun-Yo-Matic X-RayK240736 · 510(k) | Disior Ltd | Radiology | QIH | database entry | |
| Tyto Insights for Crackles DetectionK240555 · 510(k) | Tyto Care Ltd. | Anesthesiology | PHZ | database entry | |
| Hyper Insight - ICHK240353 · 510(k) | SK Inc. | Radiology | QAS | database entry | |
| VEA AlignK240582 · 510(k) | EOS imaging | Radiology | QIH | database entry | |
| eCARTv5 Clinical Deterioration SuiteK233253 · 510(k) | AgileMD, Inc. | Cardiovascular | QNL | database entry | |
| V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic UlK240631 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| O-arm O2 Imaging SystemK240465 · 510(k) | Medtronic Navigation, Inc | Radiology | OWB | database entry | |
| Medihub ProstateK233196 · 510(k) | JLK Inc. | Radiology | QIH | database entry | |
| Tempus ECG-AFK233549 · 510(k) | Tempus AI, Inc. | Cardiovascular | SBQ | database entry | |
| SMART Bun-Yo-Matic CTK240642 · 510(k) | Disior Ltd | Radiology | QIH | database entry | |
| SIS SystemK241083 · 510(k) | Surgical Information Sciences, Inc. | Radiology | QIH | database entry | |
| Clarius OB AIK233955 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| Radiography 7300 CK233662 · 510(k) | Philips Medical Systems DMC GmbH | Radiology | KPR | database entry | |
| Relu CreatorK233925 · 510(k) | Relu BV | Radiology | QIH | database entry | |
| RS85 Diagnostic Ultrasound SystemK240516 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| ImpalaK232035 · 510(k) | AliveCor, Inc. | Cardiovascular | DPS | database entry | |
| CorvairK231010 · 510(k) | AliveCor, Inc. | Cardiovascular | MHX | database entry | |
| Cardiac CT Function Software ApplicationK241038 · 510(k) | Circle Cardiovascular Imaging | Radiology | QIH | database entry | |
| EFAI Bonesuite XR Bone Age Pro Assessment SystemK234042 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | QIH | database entry | |
| CINA-VCFK240612 · 510(k) | Avicenna.AI | Radiology | QFM | database entry | |
| uPMR 790K234154 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | OUO | database entry | |
| LVivo IQSK240769 · 510(k) | DiA Imaging Analysis Ltd. | Radiology | QIH | database entry | |
| Syngo Carbon Enterprise AccessK240294 · 510(k) | Siemens Healthcare GmbH | Radiology | LLZ | database entry | |
| VinDr-MammoK233108 · 510(k) | VinBigData Joint Stock Company | Radiology | QFM | database entry | |
| YSIO X.preeK233543 · 510(k) | Siemens Medical Solutions | Radiology | KPR | database entry | |
| DentalMonitoringDEN230035 · De Novo | Dental Monitoring SAS | Dental | SBC | database entry | |
| uOmnispace.CTK233209 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | QIH | database entry | |
| RAYDENT SWK233625 · 510(k) | RAY Co., Ltd. | Dental | PNN | database entry | |
| Heuron ICHK233247 · 510(k) | Heuron Co., Ltd. | Radiology | QAS | database entry | |
| BriefCase-QuantificationK241112 · 510(k) | Aidoc Medical, Ltd. | Radiology | QIH | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.