226 devices · 161 companies · 2023
AI-enabled medical devices FDA authorized in 2023
226 devices authorized in 2023, 2023, from 161 companies across 57 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (220 of 226 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2023
- QIH · Automated Radiological Image Processing Software44
- LLZ · System, Image Processing, Radiological23
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic19
- LNH · System, Nuclear Magnetic Resonance Imaging16
- JAK · System, X-Ray, Tomography, Computed15
- QAS · Radiological Computer-Assisted Triage And Notification Software11
- MYN · Analyzer, Medical Image10
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions8
- QKB · Radiological Image Processing Software For Radiation Therapy7
- KPS · System, Tomography, Computed, Emission6
- MUJ · System, Planning, Radiation Therapy Treatment5
- QNP · Gastrointesinal Lesion Software Detection System4
- HAW · Neurological Stereotaxic Instrument4
- DQK · Computer, Diagnostic, Programmable4
- MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)3
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2
- QNL · Medium-Term Adjunctive Predictive Cardiovascular Indicator2
- OEB · Lung Computed Tomography System, Computer-Aided Detection2
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture2
- IYO · System, Imaging, Pulsed Echo, Ultrasonic2
- OOG · Knee Arthroplasty Implantation System1
- PHZ · Abnormal Breath Sound Device1
- QZF · Gastrointestinal Capsule Endoscopy Analysis Software Device1
- QUO · Adjunctive Heart Failure Status Indicator1
- QRG · Ultrasound Guided Nerve Block Assist1
- LDK · Device, Sensing, Optical Contour1
- QYE · Reduced Ejection Fraction Machine Learning-Based Notification Software1
- JOY · Device, Automated Cell-Locating1
- JAA · System, X-Ray, Fluoroscopic, Image-Intensified1
- QXZ · Adjunctive Epicardial Vascular Physiologic Status Indicator1
- QXX · Coronary Artery Disease Machine Learning-Based Notification Software1
- JIR · Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)1
- QME · Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1
- QTZ · Radiological Image Processing Software For Ablation Therapy Planning And Evaluation1
- DPS · Electrocardiograph1
- OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph1
- QXO · Cardiovascular Machine Learning-Based Notification Software1
- OLO · Orthopedic Stereotaxic Instrument1
- QJU · Image Acquisition And/Or Optimization Guided By Artificial Intelligence1
- QDB · Photoplethysmograph Analysis Software For Over-The-Counter Use1
- DQD · Stethoscope, Electronic1
- QWZ · Prognostic Test For Assessment Of Chronic Kidney Disease Progression1
- QPF · Pediatric Autism Spectrum Disorder Diagnosis Aid1
- PIB · Diabetic Retinopathy Detection Device1
- QFJ · Intravascular Bleed Monitor1
- OMB · Automatic Event Detection Software For Full-Montage Electroencephalograph1
- QDA · Electrocardiograph Software For Over-The-Counter Use1
- PQP · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System1
- PGW · Ear, Nose, And Throat Stereotaxic Instrument1
- QVT · Monitor For Opioid Induced Impairment Of Oxygenation1
- DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency1
- GYD · Transducer, Tremor1
- QVD · Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan1
- MNR · Ventilatory Effort Recorder1
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1
- QVE · Adjunctive Pain Measurement Device For Anesthesiology1
- GXY · Electrode, Cutaneous1
Panels
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.10
- Canon Medical Systems Corporation7
- Shanghai United Imaging Healthcare Co., Ltd.6
- Annalise-AI Pty Ltd6
- Brainlab AG6
- Aidoc Medical, Ltd.5
- Samsung Medison CO., LTD.4
- Brainomix Limited4
- Qure.ai Technologies3
- GE Medical Systems Ultrasound and Primary care Diagnostics,3
- Medtronic, Inc.3
- Clarius Mobile Health Corp.3
- iSchemaView, Inc.3
- GE Medical Systems, LLC3
- VideaHealth, Inc.2
- Nobel Biocare AB2
- Ceevra, Inc.2
- Siemens Healthcare GmbH2
- Philips Ultrasound LLC2
- Exo Inc2
- Axial Medical Printing Limited2
- MIM Software Inc.2
- Philips Ultrasound2
- Siemens Medical Solutions U.S.A.2
- BK Medical Aps2
- Hyperfine, Inc.2
- Ever Fortune.AI Co., Ltd.2
- Imagen Technologies, Inc2
- Volta Medical2
- Overjet, Inc2
- Viz.ai, Inc.2
- GE Medical Systems SCS2
- Manteia Technologies Co., Ltd.2
- GE Healthcare2
- Olea Medical2
The newest 150 devices
226 devices authorized in 2023 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 |
|---|---|---|---|---|---|
| TumorSight VizK231130 · 510(k) | SimBioSys, Inc. | Radiology | QIH | database entry | |
| MAGNETOM SolaK232535 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| ART-PlanK232479 · 510(k) | TheraPanacea | Radiology | MUJ | database entry | |
| qXR-LNK231805 · 510(k) | Qure.ai Technologies | Radiology | MYN | database entry | |
| HM70 EVO Diagnostic Ultrasound SystemK233112 · 510(k) | Samsung Medison CO., LTD. | Radiology | IYN | database entry | |
| uOmnispace.MIK233176 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LLZ | database entry | |
| United Orthopedic Knee Patient Specific InstrumeK230850 · 510(k) | Enhatch, Inc. | Orthopedic | OOG | database entry | |
| MAGNETOM Cima.XK231587 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| iQ-solutionsK231929 · 510(k) | Sydney Neuroimaging Analysis Centre Pty Ltd | Radiology | QIH | database entry | |
| EW10-EC02 Endoscopy Support ProgramK230751 · 510(k) | FUJIFILM Corporation | Gastroenterology-Urology | QNP | database entry | |
| Videa Dental AssistK232384 · 510(k) | VideaHealth, Inc. | Radiology | MYN | database entry | |
| StrokeViewer PerfusionK231570 · 510(k) | NICo-Lab B.V. | Radiology | LLZ | database entry | |
| QP-BrainK232231 · 510(k) | Quibim S.L. | Radiology | QIH | database entry | |
| Tyto Insights for Wheeze DetectionK232237 · 510(k) | Tyto Care Ltd. | Anesthesiology | PHZ | database entry | |
| NaviCam ProScanDEN230027 · De Novo | Ankon Technologies co., ltd | Gastroenterology-Urology | QZF | database entry | |
| Transpara Density 1.0.0K232096 · 510(k) | Screenpoint Medical B.V. | Radiology | QIH | database entry | |
| DTX Studio ClinicK231898 · 510(k) | Nobel Biocare AB | Radiology | LLZ | database entry | |
| BonelogicK223757 · 510(k) | Disior Ltd | Radiology | LLZ | database entry | |
| LOGIQ TotusK232381 · 510(k) | GE Medical Systems Ultrasound and Primary care Diagnostics, | Radiology | IYN | database entry | |
| Myocardial Strain Software ApplicationK232661 · 510(k) | Circle Cardiovascular Imaging | Radiology | LLZ | database entry | |
| Aquilion Serve SPK233334 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| LINQ II Insertable Cardiac MonitorK233562 · 510(k) | Medtronic, Inc. | Cardiovascular | MXD | database entry | |
| Adravision PerioK232440 · 510(k) | Adra Corporation | Radiology | QIH | database entry | |
| Ceevra Reveal 3+K233568 · 510(k) | Ceevra, Inc. | Radiology | QIH | database entry | |
| Syngo Carbon ClinicalsK232856 · 510(k) | Siemens Healthcare GmbH | Radiology | QIH | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK233545 · 510(k) | Philips Ultrasound LLC | Radiology | IYN | database entry | |
| 6440 MyLabX90K230179 · 510(k) | Esaote S.p.A. | Radiology | IYN | database entry | |
| BriefCase-QuantificationK231631 · 510(k) | Aidoc Medical, Ltd. | Radiology | JAK | database entry | |
| syngo.via MI WorkflowsK232000 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| ClearPoint SystemK233243 · 510(k) | ClearPoint Neuro Inc. | Neurology | HAW | database entry | |
| Brainomix 360 Triage StrokeK232496 · 510(k) | Brainomix Limited | Radiology | QAS | database entry | |
| AI PlatformK232501 · 510(k) | Exo Inc | Radiology | QIH | database entry | |
| Axial3D InsightK232841 · 510(k) | Axial Medical Printing Limited | Radiology | QIH | database entry | |
| MAGNETOM Avanto fitK232494 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| BriefCase-QuantificationK232083 · 510(k) | Aidoc Medical, Ltd. | Radiology | QIH | database entry | |
| Clarius Bladder AIK232257 · 510(k) | Clarius Mobile Health Corp. | Radiology | QIH | database entry | |
| BraveCXK223754 · 510(k) | Bering Ltd | Radiology | QFM | database entry | |
| MAGNETOM Free.MaxK231617 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| BriefCase-QuantificationK230534 · 510(k) | Aidoc Medical, Ltd. | Radiology | QIH | database entry | |
| Contour ProtégéAIK231765 · 510(k) | MIM Software Inc. | Radiology | QKB | database entry | |
| LOGIQ E10K231966 · 510(k) | GE Medical Systems Ultrasound and Primary care Diagnostics, | Radiology | IYN | database entry | |
| LOGIQ E10s, LOGIQ FortisK231989 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostic, | Radiology | IYN | database entry | |
| Lunit INSIGHT DBTK231470 · 510(k) | Lunit Inc. | Radiology | QDQ | database entry | |
| aprevo Digital SegmentationK231955 · 510(k) | Carlsmed, Inc. | Radiology | QIH | database entry | |
| BriefCase-TriageK232751 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| Voluson Expert 22, Voluson Expert 20, Voluson ExK231965 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| ACUSON Sequoia Diagnostic Ultrasound System, ACUK232145 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | IYN | database entry | |
| MeVis Liver SuiteK232045 · 510(k) | MeVis Medical Solutions AG | Radiology | JAK | database entry | |
| SwiftMRK230854 · 510(k) | AIRS Medical Inc. | Radiology | LLZ | database entry | |
| Lumify Diagnostic Ultrasound SystemK232500 · 510(k) | Philips Ultrasound | Radiology | IYN | database entry | |
| SignalHFK230842 · 510(k) | Implicity Inc. | Cardiovascular | QNL | database entry | |
| Rapid SDHK232436 · 510(k) | iSchemaView, Inc. | Radiology | QAS | database entry | |
| AI-Rad Companion Brain MRK232305 · 510(k) | Siemens Medical Solutions U.S.A. | Radiology | QIH | database entry | |
| MAGNETOM VidaK231560 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| Ultrasound System 1300K231764 · 510(k) | BK Medical Aps | Radiology | IYN | database entry | |
| Sonix HealthK230209 · 510(k) | Ontact Health Co., Ltd. | Radiology | QIH | database entry | |
| Veuron-Brain-pAb3K231642 · 510(k) | Heuron Co., Ltd. | Radiology | LLZ | database entry | |
| SpotLight/SpotLight DuoK230370 · 510(k) | Arineta Ltd. | Radiology | JAK | database entry | |
| NeuViz 128 Multi-Slice CT Scanner SystemK230220 · 510(k) | Neusoft Medical Systems Co., Ltd. | Radiology | JAK | database entry | |
| Denti.AI DetectK230144 · 510(k) | Denti.AI Technology, Inc. | Radiology | MYN | database entry | |
| Vivio LVEDP SystemK223905 · 510(k) | Avicena, LLC | Cardiovascular | QUO | database entry | |
| ScanNav Anatomy Peripheral Nerve BlockK232787 · 510(k) | Intelligent Ultrasound Limited | Anesthesiology | QRG | database entry | |
| Swoop Portable MR Imaging SystemK232760 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| cmAngio V1.0K232367 · 510(k) | CureMetrix, Inc. | Radiology | QIH | database entry | |
| Clarius Ultrasound ScannerK232704 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| DeepTek CXR Analyzer v1.0K231001 · 510(k) | DeepTek Medical Imaging Pvt Ltd | Radiology | MYN | database entry | |
| Momentum SpineK232023 · 510(k) | Momentum Health Inc. | Radiology | LDK | database entry | |
| EFAI NeuroSuite CT ICH Assessment SystemK231025 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | QAS | database entry | |
| VUNO Med-DeepBrainK231398 · 510(k) | VUNO Inc. | Radiology | QIH | database entry | |
| uMI PanoramaK232712 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| V8/H8 Diagnostic Ultrasound System, V7/H7 DiagnoK231772 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| Lung-CADK230085 · 510(k) | Imagen Technologies, Inc | Radiology | MYN | database entry | |
| HipCheckK230045 · 510(k) | Stryker Corp. | Radiology | QIH | database entry | |
| Brainomix 360 Triage LVOK231837 · 510(k) | Brainomix Limited | Radiology | QAS | database entry | |
| Low Ejection Fraction AI-ECG AlgorithmK232699 · 510(k) | Anumana, Inc. | Cardiovascular | QYE | database entry | |
| Volta AF-XplorerK232616 · 510(k) | Volta Medical | Cardiovascular | DQK | database entry | |
| OFIX MIS AppK230252 · 510(k) | Orthofix US LLC | Radiology | LLZ | database entry | |
| EFAI RTSUITE CT HCAP-Segmentation SystemK231928 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | QKB | database entry | |
| Annalise Enterprise CTB Triage TraumaK231767 · 510(k) | Annalise-AI Pty Ltd | Radiology | QAS | database entry | |
| qXR-CTRK231149 · 510(k) | Qure.ai Technologies | Radiology | QIH | database entry | |
| JazzK223659 · 510(k) | AI Medical AG | Radiology | LLZ | database entry | |
| Annalise Enterprise CTB Triage TraumaK231384 · 510(k) | Annalise-AI Pty Ltd. | Radiology | QAS | database entry | |
| Overjet Periapical Radiolucency AssistK231678 · 510(k) | Overjet, Inc | Radiology | MYN | database entry | |
| Aquilion ServeK231281 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| AI100 with ShonitK221309 · 510(k) | SigTuple Technologies Pvt. Ltd. | Hematology | JOY | database entry | |
| NEUROShieldK220034 · 510(k) | In-Med Prognostics L3C | Radiology | LLZ | database entry | |
| Lung-CADK223811 · 510(k) | Imagen Technologies, Inc | Radiology | MYN | database entry | |
| Cartesion PrimeK231748 · 510(k) | Canon Medical Systems Corporation | Radiology | KPS | database entry | |
| XIDF-AWS801, Angio WorkstationK232526 · 510(k) | Canon Medical Systems Corporation | Radiology | JAA | database entry | |
| Alignment System Cranial, Alignment Software CraK223864 · 510(k) | Brainlab AG | Neurology | HAW | database entry | |
| Cleerly ISCHEMIAK231335 · 510(k) | Cleerly, Inc | Cardiovascular | QXZ | database entry | |
| CorVista SystemK232686 · 510(k) | CorVista Health, Inc. | Cardiovascular | QXX | database entry | |
| Minuteful-kidney testK222921 · 510(k) | Healthy.io Ltd. | Clinical Chemistry | JIR | database entry | |
| DeepXrayK223621 · 510(k) | Alpha Intelligence Manifolds, Inc. | Radiology | QIH | database entry | |
| CARTO 3 EP Navigation System Software V8.0K231207 · 510(k) | Biosense Webster, Inc. | Cardiovascular | DQK | database entry | |
| MAGNETOM Viato.MobileK232482 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| FaceHeart Vitals Software Development KitK223622 · 510(k) | FaceHeart Corp. | Cardiovascular | QME | database entry | |
| Vantage Galan 3T, MRT-3020, V9.0 with AiCE ReconK230355 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| VisAble.IOK223639 · 510(k) | TechsoMed | Radiology | QTZ | database entry | |
| AIRAscoreK223180 · 510(k) | AIRAmed GmbH | Radiology | LLZ | database entry | |
| Withings Scan Monitor 2.0K230812 · 510(k) | Withings | Cardiovascular | DPS | database entry | |
| qXR-PTX-PEK230899 · 510(k) | Qure.ai Technologies | Radiology | QFM | database entry | |
| Dreem 3SK223539 · 510(k) | Beacon Biosignals, Inc. | Neurology | OLZ | database entry | |
| Annalise Enterprise CTB Triage-OHK231094 · 510(k) | Annalise-AI Pty Ltd | Radiology | QAS | database entry | |
| Viz HCMDEN230003 · De Novo | Viz.ai, Inc. | Cardiovascular | QXO | database entry | |
| VisiRad XRK223133 · 510(k) | Imidex Inc. | Radiology | MYN | database entry | |
| Spine PlanningK223553 · 510(k) | Brainlab AG | Neurology | OLO | database entry | |
| Brainomix 360 Triage ICHK231195 · 510(k) | Brainomix Limited | Radiology | QAS | database entry | |
| Rapid Aneurysm Triage and NotificationK230074 · 510(k) | iSchemaView Inc. | Radiology | QFM | database entry | |
| Global Hypoperfusion IndexK231038 · 510(k) | Edwards Lifesciences, LLC | Cardiovascular | QNL | database entry | |
| uMI PanoramaK231572 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| ANDIK230913 · 510(k) | Imeka Solutions, Inc. | Radiology | QIH | database entry | |
| ME-APDSK223473 · 510(k) | Magentiq Eye LTD | Gastroenterology-Urology | QNP | database entry | |
| Sonio DetectK230365 · 510(k) | Sonio | Radiology | IYN | database entry | |
| UltraSight AI GuidanceK223347 · 510(k) | UltraSight Inc. | Radiology | QJU | database entry | |
| OptimMRIK230150 · 510(k) | RebrAIn, SAS | Radiology | QIH | database entry | |
| Cranial Navigation, Navigation Software Cranial,K223288 · 510(k) | Brainlab AG | Neurology | HAW | database entry | |
| Irregular Rhythm Notification FeatureK231173 · 510(k) | Apple Inc. | Cardiovascular | QDB | database entry | |
| uOmnispaceK230039 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd | Radiology | QIH | database entry | |
| syngo.CT Lung CADK231157 · 510(k) | Siemens Healthcare GmbH | Radiology | OEB | database entry | |
| Brainlab Elements Image Fusion, ContouringK223106 · 510(k) | Brainlab AG | Radiology | QIH | database entry | |
| Ez3D-i /E3K231757 · 510(k) | Ewoosoft Co., Ltd | Radiology | QIH | database entry | |
| Biograph Vision.X and Biograph Vision.X EdgeK231833 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | KPS | database entry | |
| Spine Auto ViewsK223424 · 510(k) | GE Medical Systems SCS | Radiology | JAK | database entry | |
| ECHELON Synergy MRI systemK223426 · 510(k) | FUJIFILM Healthcare Corporation | Radiology | LNH | database entry | |
| AusculThing ACCK230823 · 510(k) | AusculThing Oy | Cardiovascular | DQD | database entry | |
| MOZI TPSK223724 · 510(k) | Manteia Technologies Co., Ltd. | Radiology | MUJ | database entry | |
| Spine CAMPK231668 · 510(k) | Medical Metrics, Inc. | Radiology | QIH | database entry | |
| Axial3D InsightK222745 · 510(k) | Axial Medical Printing Limited | Radiology | QIH | database entry | |
| KidneyIntelX.dkdDEN200052 · De Novo | Renalytix AI, Inc. | Clinical Chemistry | QWZ | database entry | |
| EarliPointK230337 · 510(k) | EarliTec Diagnostics, Inc | Neurology | QPF | database entry | |
| Bladder AIK230497 · 510(k) | Exo Inc | Radiology | QIH | database entry | |
| HepaFatSmartK231459 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | LNH | database entry | |
| Voluson SWIFTK230346 · 510(k) | GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC | Radiology | IYN | database entry | |
| DeepCatchK223556 · 510(k) | MEDICALIP Co., Ltd | Radiology | QIH | database entry | |
| IB Lab LAMAK223646 · 510(k) | IB Lab GmbH | Radiology | QIH | database entry | |
| EyeArt v2.2.0K223357 · 510(k) | Eyenuk, Inc. | Ophthalmic | PIB | database entry | |
| CAC SoftwareK230112 · 510(k) | Imbio, Inc. | Radiology | JAK | database entry | |
| FEops HEARTguideTM, FEops HEARTguideTM ALPACAK223855 · 510(k) | FEops nv | Radiology | QIH | database entry | |
| Sonic DLK223523 · 510(k) | GE Medical Systems,LLC (GE Healthcare) | Radiology | LNH | database entry | |
| Saranas Early Bird Bleed Monitoring SystemK230273 · 510(k) | Saranas Inc. | Cardiovascular | QFJ | database entry | |
| Critical Care Suite with Pneumothorax DetectionK223491 · 510(k) | GE Medical Systems, LLC | Radiology | QBS | database entry | |
| Ceribell Status Epilepticus MonitorK223504 · 510(k) | Ceribell, Inc. | Neurology | OMB | database entry | |
| Genius AI Detection 2.0 with CC-MLO CorrelationK230096 · 510(k) | Hologic, Inc. | Radiology | QDQ | database entry | |
| GI Genius System 100 and GI Genius System 200K231143 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | QNP | database entry | |
| AutoplaqueK212758 · 510(k) | Cedars-Sinai Medical Center: AIM | Radiology | LLZ | database entry | |
| Radiation Planning AssistantK222728 · 510(k) | University of Texas, MD Anderson Cancer Center | Radiology | MUJ | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK231190 · 510(k) | Philips Ultrasound LLC | Radiology | IYN | database entry | |
| SubtleMRK223623 · 510(k) | Subtle Medical Inc. | Radiology | LLZ | database entry | |
| Neurophet AQUAK220437 · 510(k) | NEUROPHET, Inc. | Radiology | LLZ | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.