Table 1.
List of AI-equipped medical devices approved by the US FDA.
| No. | FDA Approval Number | Product Name (Company) | Description | Regulation Medical Specialty | Decision Date | Regulatory Class (Submission Type) |
|---|---|---|---|---|---|---|
| 1 | K140933 | AliveCor Heart Monitor (AliveCor) |
An ECG recording device using machine learning techniques to detect abnormal heart rhythms. | Cardiovascular | 08/15/2014 | Class II (510(k)) |
| 2 | K143468 | QbCheck (Qbtech) |
A non-invasive test using AI for diagnosis and treatment of ADHD in children. | Neurology | 03/22/2016 | Unclassified (510(k)) |
| 3 | K160016 | Steth IO (StratoScientific) |
An acoustic device using AI to aid in the identification of abnormal heart and lung sounds. | Cardiovascular | 07/15/2016 | Class II (510(k)) |
| 4 | K163253 | Arterys Cardio DL (Arterys) | A software using deep learning to visualize and quantify cardiovascular MR images. | Radiology | 01/05/2017 | Class II (510(k)) |
| 5 | K161328 | CANTAB Mobile (Cambridge Cognition) | An iPad-based memory-assessment tool for older adults. | Neurology | 01/13/2017 | Class II (510(k)) |
| 6 | K162627 | EnsoSleep (EnsoData) | An AI sleep scoring and analysis solution that automates event detection during sleep. | Neurology | 03/31/2017 | Class II (510(k)) |
| 7 * | K162574 | AmCAD-US (AmCad BioMed Corporation) | A software to visualize and quantify ultrasound image data with backscattered signals. | Radiology | 05/30/2017 | Class II (510(k)) |
| 8 * | DEN170022 | QuantX (Quantitative Insights) | An AI-equipped diagnosis system to aid in accurate diagnosis of breast cancer. | Radiology | 07/19/2017 | Class II (De Novo) |
| 9 | K172311 | BioFlux Device (Biotricity) | A remote patient monitoring platform with AI. | Cardiovascular | 12/15/2017 | Class II (510(k)) |
| 10 | K171056 | WAVE Clinical Platform (Excel Medical Electronics) | A patient surveillance and predictive algorithm platform using AI. | Cardiovascular | 01/04/2018 | Class II (510(k)) |
| 11 * | K173542 | Arterys Oncology DL (Arterys) |
An AI-based, cloud-based medical imaging software that automatically measures and tracks lesions and nodules in MRI and CT scans. | Radiology | 01/25/2018 | Class II (510(k)) |
| 12 | DEN170073 | ContaCT (Viz.AI) | An AI algorithm to analyze CT scans and detect signs of stroke. | Radiology | 02/13/2018 | Class II (De Novo) |
| 13 | K170540 | DM-Density (Densitas) | A machine learning application that provides on demand automated breast density assessments at point-of-care. | Radiology | 02/23/2018 | Class II (510(k)) |
| 14 | P160007 | Guardian Connect System (Medtronic MiniMed) | A continuous glucose monitor with AI assistance. | Clinical Chemistry | 03/08/2018 | PMA |
| 15 | DEN180001 | IDx-DR (IDx) | A software program that uses an AI algorithm to analyze retinal images. | Ophthalmic | 04/11/2018 | Class II (De Novo) |
| 16 | K173931 | MindMotion GO (MindMaze) | A gamified neurorehabilitation therapy platform using AI. | Physical Medicine | 05/17/2018 | Class II (510(k)) |
| 17 | K180455 | NeuralBot (Neural Analytics) | A lucid robotic ultrasound system for brain blood flow assessment. | Radiology | 05/22/2018 | Class II (510(k)) |
| 18 | DEN180005 | OsteoDetect (Imagen Technologies) | A computer-aided detection and diagnostic software that uses an AI algorithm to analyze two-dimensional X-ray images for signs of distal radius fracture. | Radiology | 05/24/2018 | Class II (De Novo) |
| 19 | K173821 | LungQ (Thirona Corporation) | A lung quantification software to analyze chest CT scans. | Radiology | 06/05/2018 | Class II (510(k)) |
| 20 | DEN170043 | DreaMed Advisor Pro (DreaMed Diabetes) | An AI-powered technology to seamlessly treat patients remotely with its virtual diabetes management service. | Clinical Chemistry | 06/12/2018 | Class II (De Novo) |
| 21 | K172983 | HealthCCS (Zebra Medical Vision) | An AI-powered software that can be used to evaluate calcified plaques in the coronary arteries. | Radiology | 06/13/2018 | Class II (510(k)) |
| 22 | K173780 | EchoMD Automated Ejection Fraction Software (Bay Labs) | A system that enables fully automated AI echocardiogram analysis. | Radiology | 06/14/2018 | Class II (510(k)) |
| 23 | K180647 | BriefCase (Aidoc Medical) | An AI algorithm to detect and triage abnormal findings in non-enhanced head CT images. | Radiology | 08/01/2018 | Class II (510(k)) |
| 24 | DEN180042 | Irregular Rhythm Notification Feature (Apple) | An application to detect irregular heart rhythms in pulse rate data collected by the Apple Watch photoplethysmograph sensors. | Cardiovascular | 09/11/2018 | Class II (De Novo) |
| 25 | DEN180044 | ECG App (Apple) | Applications to detect atrial fibrillations and sinus rhythms in ECG data from an Apple Watch and display the results on an iPhone. | Cardiovascular | 09/11/2018 | Class II (De Novo) |
| 26 | K173872 | FibriCheck (Qompium) | A smartphone application for the detection of heart rhythm disorders such as atrial fibrillation. | Cardiovascular | 09/28/2018 | Class II (510(k)) |
| 27 | K181771 | RightEye Vision System (RightEye) | A cloud-based system that uses objective eye movement measurements to aid in the evaluation of Parkinson’s disease. | Neurology | 09/28/2018 | Class II (510(k)) |
| 28 * | K182034 | Arterys MICA (Arterys) | An AI-based platform for analyzing medical images such as MRI and CT. | Radiology | 10/17/2018 | Class II (510(k)) |
| 29 | K182177 | Accipio Ix (MaxQ-AI) | An AI-enabled software workflow tool that aids in identifying acute intracranial hemorrhage and prioritizing the treatment of strokes or head trauma. | Radiology | 10/26/2018 | Class II (510(k)) |
| 30 | K181939 | icobrain (icometrix) | A software that extracts clinically meaningful information from brain CT or MRI scans of patients with multiple sclerosis, dementia or brain injury. | Radiology | 11/06/2018 | Class II (510(k)) |
| 31 | K180432 | AI-ECG Platform (Shenzhen Carewell Electronics) | A software package which is a distributed ECG auto analysis system designed to assist in measuring and interpreting 12-lead resting ECG with an AI algorithm. | Cardiovascular | 11/19/2018 | Class II (510(k)) |
| 32 | K182218 | FerriSmart Analysis System (Resonance Health Analysis Service) | An automated system for measuring liver iron concentration. | Radiology | 11/30/2018 | Class II (510(k)) |
| 33 * | K182336 | SubtlePET (Subtle Medical) | An AI-powered technology that enables centers to deliver a faster and safer patient scanning experience, while enhancing exam throughput and provider profitability. | Radiology | 11/30/2018 | Class II (510(k)) |
| 34 | K173681 | reSET-O (Pear Therapeutics) | A Prescription Digital Therapeutic (PDT) platform for the treatment of Opioid Use Disorder. | Neurology | 12/10/2018 | Class II (510(k)) |
| 35 | K181861 | Embrace (Empatica) | An epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. | Neurology | 12/20/2018 | Class II (510(k)) |
| 36 | K182130 | iSchemaView RAPID (iSchemaView) | An AI-enhanced advanced medical imaging for stroke. | Radiology | 12/27/2018 | Class II (510(k)) |
| 37 | K182564 | Quantib ND (Quantib) | An AI solution that helps radiologists read MRI brain scans. | Radiology | 12/27/2018 | Class II (510(k)) |
| 38 | K182456 | Study Watch (Verily Life Sciences) | A wearable device to record, store, transfer, and display ECG rhythms. | Cardiovascular | 01/17/2019 | Class II (510(k)) |
| 39 | K182344 | RhythmAnalytics (Biofourmis Singapore) | An AI-powered software to detect irregular heart rhythms when ECG data are uploaded. | Cardiovascular | 03/07/2019 | Class II (510(k)) |
| 40 * | K183285 | cmTriage (CureMetrix) | An AI-based triage software for mammography. | Radiology | 03/08/2019 | Class II (510(k)) |
| 41 | K181823 | KardiaAI (AliveCor) | An AI-based software analysis library to assess ambulatory ECG rhythms from adult subjects. | Cardiovascular | 03/11/2019 | Class II (510(k)) |
| 42 | K181352 | Loop System (Spry Health) | A tool to collect and transfer physiological data of patients in the home environment. | Cardiovascular | 03/29/2019 | Class II (510(k)) |
| 43 * | K183202 | Deep Learning Image Reconstruction (GE Medical Systems) | A deep learning-based CT image reconstruction technology. | Radiology | 04/12/2019 | Class II (510(k)) |
| 44 | K181988 | eMurmur ID (CSD Labs) | A software screening device that uses a smartphone, electronic stethoscope and machine learning to automate the detection of heart murmurs. | Cardiovascular | 04/17/2019 | Class II (510(k)) |
| 45 | K190362 | HealthPNX (Zebra Medical Vision) | A radiological computer-assisted triage and notification software system. | Radiology | 05/06/2019 | Class II (510(k)) |
| 46 * | K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE (Canon Medical Systems Corporation) | A device to acquire and display cross-sectional volumes of the whole body, including the head, with the capability of imaging whole organs in a single rotation. | Radiology | 06/12/2019 | Class II (510(k)) |
| 47 * | K191384 | RayCare 2.3 (RaySearch Laboratories) | An oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. | Radiology | 07/08/2019 | Class II (510(k)) |
| 48 | K183322 | physIQ Heart Rhythm and Respiratory Module (physIQ) | A device for the calculation of heart rate and heart rate variability, the detection of atrial fibrillation and the determination of respiration rate using ambulatory ECG and triaxial accelerometer data. | Cardiovascular | 07/10/2019 | Class II (510(k)) |
| 49 | K191272 | Current Wearable Health Monitoring System (Current Health) | A device for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities. | Cardiovascular | 07/12/2019 | Class II (510(k)) |
| 50 | K182384 | ACR | LAB Urine Analysis Test System (Healthy.io) | A device for the semi-quantitative detection of albumin and creatinine in urine, using a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. | Clinical Chemistry | 07/26/2019 | Class II (510(k)) |
| 51 | K183271 | AI-Rad Companion (Pulmonary) (Siemens Medical Solutions USA) | An image processing software that provides a quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and physicians in the evaluation and assessment of lung disease. | Radiology | 07/26/2019 | Class II (510(k)) |
| 52 | K183282 | Biovitals Analytics Engine (Biofourmis Singapore) | An AI-based software engine used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. | Cardiovascular | 08/15/2019 | Class II (510(k)) |
| 53 | K183268 | AI-Rad Companion (Cardiovascular) (Siemens Medical Solutions USA) | An image processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and physicians in the evaluation and assessment of cardiovascular diseases. | Radiology | 09/10/2019 | Class II (510(k)) |
| 54 | K190815 | BrainScope TBI (BrainScope Company) | A portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of concussion/mild traumatic brain injury (mTBI). | Neurology | 09/11/2019 | Class II (510(k)) |
| 55 | K191688 | SubtleMR (Subtle Medical) | An image processing software that can be used for image enhancement in MRI images. | Radiology | 09/16/2019 | Class II (510(k)) |
| 56 * | K191994 | ProFound AI Software V2.1 (iCAD) | A CAD software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. | Radiology | 10/04/2019 | Class II (510(k)) |
| 57 | K191713 | CS-series-FP Radiographic/Fluoroscopic Systems with Optional CA-100S/FluoroShield (Omega Medical Imaging) | A modification device to provide an automated region of interest that reduces exposure to the patient and operator. | Radiology | 10/04/2019 | Class II (510(k)) |
| 58 | K191171 | EchoGo Core (Ultromics) | A software for use in quantification and reporting of results of cardiovascular function to support physician diagnosis. | Radiology | 11/13/2019 | Class II (510(k)) |
| 59 * | K192287 | Transpara (ScreenPoint Medical) | A device for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDM systems to identify regions suspicious for breast cancer and assess their likelihood of malignancy. | Radiology | 12/10/2019 | Class II (510(k)) |
| 60 | K192004 | Eko Analysis Software (Eko Devices) | A software to provide support to the physician in the evaluation of patients’ heart sounds and ECG’s. | Cardiovascular | 01/15/2020 | Class II (510(k)) |
| 61 | DEN190040 | Caption Guidance (Caption Health) | A software to assist in the acquisition of cardiac ultrasound images. | Radiology | 02/07/2020 | Class II (De Novo) |
*: The product involved in the field of oncology. Abbreviations: AI, artificial intelligence; US FDA, United States Food and Drug Administration; CT, computed tomography; MRI, magnetic resonance imaging; DICOM, Digital Imaging and Communications in Medicine; ECG, electrocardiogram; FFDM, full-field digital mammography; ADHD, attention deficit hyperactivity disorder.