. 2021 Apr 14;28(1):e100301. doi: 10.1136/bmjhci-2020-100301

Table 1.

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

Approval no	Device	Manufacturer	Scheme	Date	Class	Clinical task	Device task	Device input	Device output	ML method	SaMD	Autonomy	Disease(s)
Information acquisition
K182901 ²⁶	Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE	Canon Medical Systems	PMN	July 2019	2	Diagnosis	Improve image quality and reduce noise for displaying cross-sectional volumes of the whole body.	CT	Enhanced images	DCNN	No	Information
K193170 ²⁷	Deep Learning Image Reconstruction	GE Healthcare Japan	PMN	December 2019	2	Diagnosis	Computer reconstruction of images to produce cross-sectional images of the head and whole body.	CT	Enhanced images	DNN	No	Information
K191688 ²⁸	SubtleMR	Subtle Medical	PMN	September 2019	2	Diagnosis	Reduce image noise for head, spine, neck, and knee MRI or increase image sharpness for head MRI.	MRI	Enhanced images	CNN	Yes	Information
K182336 ²⁹	SubtlePET	Subtle Medical	PMN	November 2018	2	Diagnosis	Reduce noise to increase image quality.	PET	Enhanced images	CNN	Yes	Information
Information analysis
K182616 ³⁸	NvisionVLE Imaging System	NinePoint Medical	PMN	November 2018	2	Diagnosis	Enhanced visualisation with colourised display of common image features of human tissue.	Optical coherence tomography	Coding features or events	DL	No	Information
K162627 ³⁹	EnsoSleep	EnsoData	PMN	March 2017	2	Diagnosis	Automatically score sleep studies.	Polysomnography	Coding features or events	AI	Yes	Assistive	Sleep and respiratory related sleep disorders (i)
K173780 ³⁰	EchoMD Automated Ejection Fraction Software	Bay Labs	PMN	June 2018	2	Diagnosis	Automated estimation of left ventricular ejection fraction.	Echocardiogram	Quantification	CNN	Yes	Information
K192130 ³¹	IcoBrain	Icometrix NV	PMN	December 2019	2	Diagnosis	Automatic labelling, visualisation, and volumetric quantification brain of segmentable brain structures.	CT / MRI	Quantification	AI	Yes	Information
K080762 ²³	IB Neuro	Imaging Biometrics	PMN	May 2008	2	Diagnosis	Generate parametric perfusion maps of Relative Cerebral Blood Volume, Cerebral Blood Flow, Mean Transit Time, and Time to Peak.	MRI	Quantification	ML	Yes	Information
K183268 ³²	AI-Rad Companion (Cardiovascular)	Siemens Medical Solutions USA	PMN	September 2019	2	Diagnosis	Quantification of heart volume, calcium volume in coronary arteries, and maximum aorta diameters at typical landmarks.	CT	Quantification	DL	Yes	Information	Cardiovascular diseases (i)
K183271 ⁶⁹	AI-Rad Companion (Pulmonary)	Siemens Medical Solutions USA	PMN	July 2019	2	Diagnosis	Quantification of lungs and lung lobes, and specified lung lesions.	CT	Quantification	DL	Yes	Information	disease of the lungs, Lung cancer (i)
K161322 ⁷⁰	CT CoPilot	ZepMed	PMN	December 2016	2	Diagnosis	Automatic labelling, visualisation, and volumetric quantification of segmentable brain structures.	CT	Quantification	ML	Yes	Information
K163253 ³³	Arterys Cardio DL	Arterys	PMN	January 2017	2	Diagnosis	Quantification of the blood flow to the heart and its major vessels.	MRI	Quantification	DL	Yes	Assistive
K183282 ⁶⁸	Biovitals Analytics Engine	Biofourmis Singapore	PMN	August 2019	2	Monitoring	Calculates time series Biovitals Index which reflects changes in the patient’s vital signs from their measured baseline.	Continuous biometric data from worn sensors	Quantification	ML	Yes	Assistive
K191278 ³⁴	RSI-MRI+	HealthLytix	PMN	November 2019	2	Diagnosis	Automatic prostate segmentation, quantification, and reporting.	MRI	Quantification	DL	Yes	Assistive	Prostate cancer (a)
K173939 ³⁵	Quantib Brain	Quantib B.V.	PMN	March 2018	2	Diagnosis	Automatic labelling, visualisation, and volumetric quantification of segmentable brain structures for GE Advantage Workstation or AW Server.	MRI	Quantification	ML	No	Assistive
K182564 ³⁶	Quantib ND	Quantib B.V.	PMN	December 2018	2	Diagnosis	Automatic labelling, visualisation, and volumetric quantification of segmentable brain structures for Myrian.	MRI	Quantification	ML	Yes	Assistive
K191171 ³⁷	EchoGo Core	Ultromics	PMN	November 2019	2	Diagnosis	Automatically measures standard cardiac parameters including Ejection Fraction, Global Longitudinal Strain, and Left Ventricular volume.	Echocardiogram	Quantification	ML	Yes	Assistive
Decision selection
DEN180001 ⁴⁹	Idx-DR	IDX	De novo	April 2018	2	Diagnosis	Automatically detect more than mild diabetic retinopathy in adults with diabetes.	Fundus images	Case level finding of disease	CNN	Yes	Decision	Diabetic retinopathy (i)
K181988 ⁵⁰	eMurmur ID	CSD Labs	PMN	April 2019	2	Diagnosis	Automated analysis of specific heart sounds, including S1, S2, physiological and pathological heart murmurs.	Phonocardiogram	Case level finding of disease	ML	Yes	Assistive	Heart murmur (i)
K192004 ²⁴	Eko Analysis Software	Eko Devices	PMN	January 2020	2	Diagnosis	Detects suspected heart murmurs, atrial fibrillation, and normal sinus rhythm. Calculates heart rate, QRS duration and EMAT.	Phonocardiogram & ECG	Case level finding of disease	NN	Yes	Assistive	Cardiac Arrhythmias, Heart murmur (i)
K192109 ⁵¹	KOALA	IB Lab	PMN	November 2019	2	Diagnosis	Metric measurements of the joint space width and indicators for presence of osteoarthritis on PA/AP knee X-ray images.	X-ray	Case level finding of disease	ML	Yes	Assistive	Knee Osteoarthritis (i)
DEN180005 ⁵²	OsteoDetect	Imagen Technologies	De novo	May 2018	2	Diagnosis	Identify and highlight distal radius fractures during the review of posterior-anterior and lateral radiographs of adult wrists.	X-ray	Case level finding of disease	DL	Yes	Assistive	Wrist fracture (i)
K180432 ⁵³	AI-ECG Platform	Shenzhen Carewell Electronics	PMN	November 2018	2	Diagnosis	Interprets ECG for cardiac abnormalities, such as arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes.	ECG	Case level finding of disease	AI	Yes	Assistive	Cardiac Arrhythmias (i)
K180125 ⁶⁰	Powerlook Density Assessment Software	iCad	PMN	April 2018	2	Diagnosis	Analyses the dense tissue area of each breast, providing a Category of 1–4 consistent with ACR BI-RADS fifth edition.	Digital breast tomosynthesis	Clinical grading or scoring	ML	Yes	Decision	Breast cancer (a)
K172983 ⁶¹	HealthCCS	Zebra Medical Vision	PMN	June 2018	2	Diagnosis	Quantifies calcification in the coronary arteries reporting a risk category.	CT	Clinical grading or scoring	CNN	Yes	Information	Coronary artery disease (i)
K173542 ⁶²	Arterys Oncology DL	Arterys	PMN	January 2018	2	Diagnosis	Quantification of lung nodules and liver lesions, reporting in accordance with Lung-RADS and LI-RADS.	CT / MRI	Clinical grading or scoring	DL	Yes	Assistive	Lung and liver cancers. (a)
K170540 ⁶³	DM-Density	Densitas	PMN	February 2018	2	Diagnosis	Analyses and reports breast density in accordance with the BI-RADS density classification scales.	Digital mammography	Clinical grading or scoring	AI	Yes	Assistive	Breast cancer (a)
K190442 ⁶⁴	Koios DS for Breast	Koios Medical	PMN	July 2019	2	Diagnosis	Automatically classify user-selected region(s) of interest containing a breast lesion into four BI-RADS-aligned categories.	Ultrasound	Clinical grading or scoring	ML	Yes	Assistive	Breast cancer (i)
K170568 ⁵⁴	Cardiologs	Cardiologs Technologies	PMN	June 2017	2	Diagnosis	Identification and labelling abnormal cardiac rhythms.	ECG	Identify features of disease	DL	Yes	Assistive	Cardiac Arrhythmias (i)
P080003/S 008 ⁵⁵	Selenia Dimensions 3D System High Resolution Tomosynthesis	Hologic	PMA	October 2019	3	Diagnosis	Identification of clinically relevant regions of interest for breast screening and diagnosis.	Digital breast tomosynthesis	Identify features of disease	AI	No	Assistive	Breast cancer (i)
K191994 ⁵⁶	Profound AI	iCad	PMN	October 2019	2	Diagnosis	Detect malignant soft tissue densities and calcifications in breast images.	Digital breast tomosynthesis	Identify features of disease	DL	Yes	Assistive	Breast cancer (a)
DEN170022 ⁵⁷	Quantx	Quantitative Insights	De novo	July 2017	2	Diagnosis	Analysis of selected regions, providing comparison with similar lesions with a known ground truth.	MRI	Identify features of disease	AI	Yes	Assistive	Breast cancer (a)
K161201 ⁵⁸	ClearRead CT	Riverain Technologies	PMN	September 2016	2	Diagnosis	Generates secondary vessel suppressed lung images, marking regions of interest to aid in the detection of pulmonary nodules.	CT	Identify features of disease	ML	Yes	Assistive	Lung cancers (a)
K192287 ⁵⁹	Transpara	ScreenPoint Medical BV	PMN	December 2019	2	Diagnosis	Identify regions suspicious for breast cancer and assess their likelihood of malignancy.	Digital mammography	Identify features of disease	ML	Yes	Assistive	Breast cancer (i)
K182218 ⁸⁶	FerriSmart Analysis System	Resonance Health Analysis Services	PMN	November 2018	2	Diagnosis	Measure liver iron concentration.	MRI	Quantification	CNN	Yes	Decision
K191370 ⁸⁷	DreaMed Advisor Pro	DreaMed Diabetes	PMN	July 2019	2	Treatment	Analyse blood glucose and insulin pump data to generate recommendations for optimising insulin pump dose ratios.	Blood glucose and insulin pump data	Treatment recommendations	ML	Yes	Assistive	Type 1 diabetes (i)
K190896 ⁴⁰	Briefcase (CSF)	AiDoc Medical	PMN	May 2019	2	Triage	Analyse images, notifying cases with suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.	CT	Triage notifications	AI	Yes	Decision	Cervical spine fracture (i)
K190072 ²⁵	Briefcase (ICH and PE)	AiDoc Medical	PMN	April 2019	2	Triage	Analyse images, notifying cases with suspected positive findings of Intracranial Haemorrhage or Pulmonary Embolism pathologies.	CT	Triage notifications	AI	Yes	Decision	Intracranial Haemorrhage, Pulmonary Embolism (i)
K192383 ⁴¹	Briefcase (LVO)	AiDoc Medical	PMN	December 2019	2	Triage	Analyse images, notifying cases with suspected positive findings of Large Vessel Occlusion pathologies.	CT	Triage notifications	AI	Yes	Decision	Large Vessel Occlusion (i)
K183285 ⁴²	CmTriage	CureMetrix	PMN	March 2019	2	Triage	Analyse screening mammograms, notifying cases with at least one suspicious finding at the exam level.	Digital mammography	Triage notifications	ML	Yes	Decision	Breast cancer (a)
K183182 ⁴³	Critical Care Suite	GE Medical Systems	PMN	August 2019	2	Triage	Analyse and notify cases with suspected findings of pneumothorax.	X-ray	Triage notifications	DL	Yes	Decision	Pneumothorax (i)
K182177 ⁴⁴	AccipioIx	MaxQ-AI	PMN	October 2018	2	Triage	Identify and notify cases with suspected findings of acute intracranial haemorrhage.	CT	Triage notifications	AI	Yes	Decision	Intracranial Haemorrhage (i)
DEN170073 ⁴⁵	ContaCT	Viz.AI	De novo	February 2018	2	Triage	Identify and notify cases with suspected findings of large vessel occlusion.	CT	Triage notifications	AI	Yes	Decision	Large Vessel Occlusion (i)
K192320 ⁴⁶	HealthCXR	Zebra Medical Vision	PMN	November 2019	2	Triage	Automatically identify and notify suspected findings of pleural effusion.	X-ray	Triage notifications	AI	Yes	Decision	Pleural Effusion (i)
K190424 ⁴⁷	HealthICH	Zebra Medical Vision	PMN	June 2019	2	Triage	Automatically identify and notify suspected findings of Intracranial Haemorrhage.	CT	Triage notifications	AI	Yes	Decision	Intracranial Haemorrhage (i)
K190362 ⁴⁸	HealthPNX	Zebra Medical Vision	PMN	May 2019	2	Triage	Automatically identify and notify suspected findings of Pneumothorax.	X-ray	Triage notifications	AI	Yes	Decision	Pneumothorax (i)
Action Implementation
K191713 ⁶⁷	FluoroShield	Omega Medical Imaging	PMN	October 2019	2	Procedure	Automated region of interest in fluoroscopic applications.	Fluoroscopy	Automatic control of device	AI	No	Decision
DEN190040 ⁶⁶	Caption Guidance	Bay Labs	De novo	February 2020	2	Procedure	Real-time guidance during echocardiography acquisition to assist obtaining correct images of standard diagnostic views and orientations.	Echocardiogram	Automatic control of device	DL	Yes	Assistive

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.