Table 1

Characteristics of ML medical devices approved by the US Food and Drug Administration (2008–2020)

Approval noDeviceManufacturerSchemeDateClassClinical taskDevice taskDevice inputDevice outputML methodSaMDAutonomyDisease(s)
Information acquisition
K18290126Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical SystemsPMNJuly 20192DiagnosisImprove image quality and reduce noise for displaying cross-sectional volumes of the whole body.CTEnhanced imagesDCNNNoInformation
K19317027Deep Learning Image ReconstructionGE Healthcare JapanPMNDecember 20192DiagnosisComputer reconstruction of images to produce cross-sectional images of the head and whole body.CTEnhanced imagesDNNNoInformation
K19168828SubtleMRSubtle MedicalPMNSeptember 20192DiagnosisReduce image noise for head, spine, neck, and knee MRI or increase image sharpness for head MRI.MRIEnhanced imagesCNNYesInformation
K18233629SubtlePETSubtle MedicalPMNNovember 20182DiagnosisReduce noise to increase image quality.PETEnhanced imagesCNNYesInformation
Information analysis
K18261638NvisionVLE Imaging SystemNinePoint MedicalPMNNovember 20182DiagnosisEnhanced visualisation with colourised display of common image features of human tissue.Optical coherence tomographyCoding features or eventsDLNoInformation
K16262739EnsoSleepEnsoDataPMNMarch 20172DiagnosisAutomatically score sleep studies.PolysomnographyCoding features or eventsAIYesAssistiveSleep and respiratory related sleep disorders (i)
K17378030EchoMD Automated Ejection Fraction SoftwareBay LabsPMNJune 20182DiagnosisAutomated estimation of left ventricular ejection fraction.EchocardiogramQuantificationCNNYesInformation
K19213031IcoBrainIcometrix NVPMNDecember 20192DiagnosisAutomatic labelling, visualisation, and volumetric quantification brain of segmentable brain structures.CT / MRIQuantificationAIYesInformation
K08076223IB NeuroImaging BiometricsPMNMay 20082DiagnosisGenerate parametric perfusion maps of Relative Cerebral Blood Volume, Cerebral Blood Flow, Mean Transit Time, and Time to Peak.MRIQuantificationMLYesInformation
K18326832AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USAPMNSeptember 20192DiagnosisQuantification of heart volume, calcium volume in coronary arteries, and maximum aorta diameters at typical landmarks.CTQuantificationDLYesInformationCardiovascular diseases (i)
K18327169AI-Rad Companion (Pulmonary)Siemens Medical Solutions USAPMNJuly 20192DiagnosisQuantification of lungs and lung lobes, and specified lung lesions.CTQuantificationDLYesInformationdisease of the lungs, Lung cancer (i)
K16132270CT CoPilotZepMedPMNDecember 20162DiagnosisAutomatic labelling, visualisation, and volumetric quantification of segmentable brain structures.CTQuantificationMLYesInformation
K16325333Arterys Cardio DLArterysPMNJanuary 20172DiagnosisQuantification of the blood flow to the heart and its major vessels.MRIQuantificationDLYesAssistive
K18328268Biovitals Analytics EngineBiofourmis SingaporePMNAugust 20192MonitoringCalculates time series Biovitals Index which reflects changes in the patient’s vital signs from their measured baseline.Continuous biometric data from worn sensorsQuantificationMLYesAssistive
K19127834RSI-MRI+HealthLytixPMNNovember 20192DiagnosisAutomatic prostate segmentation, quantification, and reporting.MRIQuantificationDLYesAssistiveProstate cancer (a)
K17393935Quantib BrainQuantib B.V.PMNMarch 20182DiagnosisAutomatic labelling, visualisation, and volumetric quantification of segmentable brain structures for GE Advantage Workstation or AW Server.MRIQuantificationMLNoAssistive
K18256436Quantib NDQuantib B.V.PMNDecember 20182DiagnosisAutomatic labelling, visualisation, and volumetric quantification of segmentable brain structures for Myrian.MRIQuantificationMLYesAssistive
K19117137EchoGo CoreUltromicsPMNNovember 20192DiagnosisAutomatically measures standard cardiac parameters including Ejection Fraction, Global Longitudinal Strain, and Left Ventricular volume.EchocardiogramQuantificationMLYesAssistive
Decision selection
DEN18000149Idx-DRIDXDe novoApril 20182DiagnosisAutomatically detect more than mild diabetic retinopathy in adults with diabetes.Fundus imagesCase level finding of diseaseCNNYesDecisionDiabetic retinopathy (i)
K18198850eMurmur IDCSD LabsPMNApril 20192DiagnosisAutomated analysis of specific heart sounds, including S1, S2, physiological and pathological heart murmurs.PhonocardiogramCase level finding of diseaseMLYesAssistiveHeart murmur (i)
K19200424Eko Analysis SoftwareEko DevicesPMNJanuary 20202DiagnosisDetects suspected heart murmurs, atrial fibrillation, and normal sinus rhythm. Calculates heart rate, QRS duration and EMAT.Phonocardiogram & ECGCase level finding of diseaseNNYesAssistiveCardiac Arrhythmias, Heart murmur (i)
K19210951KOALAIB LabPMNNovember 20192DiagnosisMetric measurements of the joint space width and indicators for presence of osteoarthritis on PA/AP knee X-ray images.X-rayCase level finding of diseaseMLYesAssistiveKnee Osteoarthritis (i)
DEN18000552OsteoDetectImagen TechnologiesDe novoMay 20182DiagnosisIdentify and highlight distal radius fractures during the review of posterior-anterior and lateral radiographs of adult wrists.X-rayCase level finding of diseaseDLYesAssistiveWrist fracture (i)
K18043253AI-ECG PlatformShenzhen Carewell ElectronicsPMNNovember 20182DiagnosisInterprets ECG for cardiac abnormalities, such as arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes.ECGCase level finding of diseaseAIYesAssistiveCardiac Arrhythmias (i)
K18012560Powerlook Density Assessment SoftwareiCadPMNApril 20182DiagnosisAnalyses the dense tissue area of each breast, providing a Category of 1–4 consistent with ACR BI-RADS fifth edition.Digital breast tomosynthesisClinical grading or scoringMLYesDecisionBreast cancer (a)
K17298361HealthCCSZebra Medical VisionPMNJune 20182DiagnosisQuantifies calcification in the coronary arteries reporting a risk category.CTClinical grading or scoringCNNYesInformationCoronary artery disease (i)
K17354262Arterys Oncology DLArterysPMNJanuary 20182DiagnosisQuantification of lung nodules and liver lesions, reporting in accordance with Lung-RADS and LI-RADS.CT / MRIClinical grading or scoringDLYesAssistiveLung and liver cancers. (a)
K17054063DM-DensityDensitasPMNFebruary 20182DiagnosisAnalyses and reports breast density in accordance with the BI-RADS density classification scales.Digital mammographyClinical grading or scoringAIYesAssistiveBreast cancer (a)
K19044264Koios DS for BreastKoios MedicalPMNJuly 20192DiagnosisAutomatically classify user-selected region(s) of interest containing a breast lesion into four BI-RADS-aligned categories.UltrasoundClinical grading or scoringMLYesAssistiveBreast cancer (i)
K17056854CardiologsCardiologs TechnologiesPMNJune 20172DiagnosisIdentification and labelling abnormal cardiac rhythms.ECGIdentify features of diseaseDLYesAssistiveCardiac Arrhythmias (i)
P080003/S00855Selenia Dimensions 3D System High Resolution TomosynthesisHologicPMAOctober 20193DiagnosisIdentification of clinically relevant regions of interest for breast screening and diagnosis.Digital breast tomosynthesisIdentify features of diseaseAINoAssistiveBreast cancer (i)
K19199456Profound AIiCadPMNOctober 20192DiagnosisDetect malignant soft tissue densities and calcifications in breast images.Digital breast tomosynthesisIdentify features of diseaseDLYesAssistiveBreast cancer (a)
DEN17002257QuantxQuantitative InsightsDe novoJuly 20172DiagnosisAnalysis of selected regions, providing comparison with similar lesions with a known ground truth.MRIIdentify features of diseaseAIYesAssistiveBreast cancer (a)
K16120158ClearRead CTRiverain TechnologiesPMNSeptember 20162DiagnosisGenerates secondary vessel suppressed lung images, marking regions of interest to aid in the detection of pulmonary nodules.CTIdentify features of diseaseMLYesAssistiveLung cancers (a)
K19228759TransparaScreenPoint Medical BVPMNDecember 20192DiagnosisIdentify regions suspicious for breast cancer and assess their likelihood of malignancy.Digital mammographyIdentify features of diseaseMLYesAssistiveBreast cancer (i)
K18221886FerriSmart Analysis SystemResonance Health Analysis ServicesPMNNovember 20182DiagnosisMeasure liver iron concentration.MRIQuantificationCNNYesDecision
K19137087DreaMed Advisor ProDreaMed DiabetesPMNJuly 20192TreatmentAnalyse blood glucose and insulin pump data to generate recommendations for optimising insulin pump dose ratios.Blood glucose and insulin pump dataTreatment recommendationsMLYesAssistiveType 1 diabetes (i)
K19089640Briefcase (CSF)AiDoc MedicalPMNMay 20192TriageAnalyse images, notifying cases with suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.CTTriage notificationsAIYesDecisionCervical spine fracture (i)
K19007225Briefcase (ICH and PE)AiDoc MedicalPMNApril 20192TriageAnalyse images, notifying cases with suspected positive findings of Intracranial Haemorrhage or Pulmonary Embolism pathologies.CTTriage notificationsAIYesDecisionIntracranial Haemorrhage, Pulmonary Embolism (i)
K19238341Briefcase (LVO)AiDoc MedicalPMNDecember 20192TriageAnalyse images, notifying cases with suspected positive findings of Large Vessel Occlusion pathologies.CTTriage notificationsAIYesDecisionLarge Vessel Occlusion (i)
K18328542CmTriageCureMetrixPMNMarch 20192TriageAnalyse screening mammograms, notifying cases with at least one suspicious finding at the exam level.Digital mammographyTriage notificationsMLYesDecisionBreast cancer (a)
K18318243Critical Care SuiteGE Medical SystemsPMNAugust 20192TriageAnalyse and notify cases with suspected findings of pneumothorax.X-rayTriage notificationsDLYesDecisionPneumothorax (i)
K18217744AccipioIxMaxQ-AIPMNOctober 20182TriageIdentify and notify cases with suspected findings of acute intracranial haemorrhage.CTTriage notificationsAIYesDecisionIntracranial Haemorrhage (i)
DEN17007345ContaCTViz.AIDe novoFebruary 20182TriageIdentify and notify cases with suspected findings of large vessel occlusion.CTTriage notificationsAIYesDecisionLarge Vessel Occlusion (i)
K19232046HealthCXRZebra Medical VisionPMNNovember 20192TriageAutomatically identify and notify suspected findings of pleural effusion.X-rayTriage notificationsAIYesDecisionPleural Effusion (i)
K19042447HealthICHZebra Medical VisionPMNJune 20192TriageAutomatically identify and notify suspected findings of Intracranial Haemorrhage.CTTriage notificationsAIYesDecisionIntracranial Haemorrhage (i)
K19036248HealthPNXZebra Medical VisionPMNMay 20192TriageAutomatically identify and notify suspected findings of Pneumothorax.X-rayTriage notificationsAIYesDecisionPneumothorax (i)
Action Implementation
K19171367FluoroShieldOmega Medical ImagingPMNOctober 20192ProcedureAutomated region of interest in fluoroscopic applications.FluoroscopyAutomatic control of deviceAINoDecision
DEN19004066Caption GuidanceBay LabsDe novoFebruary 20202ProcedureReal-time guidance during echocardiography acquisition to assist obtaining correct images of standard diagnostic views and orientations.EchocardiogramAutomatic control of deviceDLYesAssistive
  • Disease(s): (1) indicated disease; (a) associated disease.

  • ML method as described by manufacturer.

  • Autonomy: assistive; Information, autonomous information; Decision, autonomous decision.

  • AI, artificial intelligence; BI-RADS, Breast Imaging-Reporting and Data System; CNN, convolutional neural network; DCNN, Deep Convolutional Neural Network; DL, deep learning; DNN, deep neural network; LI-RADS, Liver Imaging-Reporting and Data System; ML, machine learning; NN, neural network; PMA, premarket approval; PMN, premarket notification; SaMD, Software as a Medical Device.