Modality
203 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Butterfly Network, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound, LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Sonio
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
QT Imaging Holdings, Inc.
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Clarius Mobile Health Corp.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ligence Uab
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Exo Imaging
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ultrasound AI
FDA product code SHE identifies this device class as Radiological Software System For Delivery Date Prediction. A radiological software system for delivery date prediction is a...
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Bioticsai, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound, LLC
Lumify Lung Application 3 assesses pleural-line appearance and lung-view quality in adults at least 18 years old using compatible Android devices and specified probes; it does not...
Ultrasight, Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ultrasight, Ltd.
UltraSight Guidance assists medical professionals other than expert sonographers with acquisition of standard two-dimensional transthoracic cardiac ultrasound views in adult...
Brightheart
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Esaote, S.P.A.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Ge Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Canon Medical Systems Corporation
Aplio i900, i800, and i700 software V9.0 are mobile multi-region diagnostic ultrasound systems for physicians and appropriately trained healthcare professionals; the submission...
Ge Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Ge Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
X9, Inc.
FDA product code SGH identifies this device class as Ultrasound Imaging For Vascular Access For Hemodialysis. Ultrasound imaging for vascular access for hemodialysis Consult the...
Philips Ultrasound, LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Deep Breathe, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ligence, UAB
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Diagnoly
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Fujifilm Sonosite Inc
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Siemens Medical Solutions USA, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary care Diagnostics
Venue, Venue Go, Venue Fit, and Venue Sprint are general point-of-care ultrasound systems for broad adult, pediatric, and neonatal applications, with model- and release-specific...
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
PIUR Imaging GmbH
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Mycardium AI Limited
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Esaote S.p.A.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
BrightHeart
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
DeepEcho
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Rivanna Medical, Inc.
Accuro 3S is portable B-mode ultrasound with SpineNav-AI for lumbar-spine scouting and epidural-depth estimation during neuraxial-anesthesia and needle or catheter placement...
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Esaote S.p.A.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Clarius Mobile Health Corp.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
BrightHeart
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
BrightHeart
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vscan Air is a wireless handheld point-of-care ultrasound system for broad adult, pediatric, and neonatal applications; K250087 adds reviewed automatic bladder-volume measurement...
Canon Medical Systems Corporation
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Exo Inc
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Clarius Mobile Health Corp.
Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Deski
FDA product code QJU identifies this device class as Image Acquisition And/Or Optimization Guided By Artificial Intelligence. A radiological acquisition and/or optimization...
DiA Imaging Analysis Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
DiA Imaging Analysis Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
DiA Imaging Analysis Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Sonio
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Samsung Medison Co., Ltd.
Samsung V8, cV8, V7, cV7, V6, and cV6 are general diagnostic ultrasound systems; K243702 adds model-specific nerve, ablation-viewing, strain, AutoEF GLS, and probe functions.
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid iq is a portable cardiovascular and general diagnostic ultrasound system; K243620 adds vascular-access support, catheter compatibility, Sleep Mode, Clarity+, and DICOM...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid T9 and Vivid T8 are cardiac-focused general ultrasound systems; this release adds vascular-access support, Clarity+, DICOM PDF, nondiagnostic remote viewing, and workflow...
Philips Ultrasound LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Sonoscape Medical Corp.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Ontact Health Co., Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Exo Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Koios Medical, Inc.
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
BrightHeart
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
iCardio.ai
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Verdure Imaging
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
DiA Imaging Analysis Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Echo IQ Ltd
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Premier, Versana Premier Lotus, and LOGIQ F are general-purpose diagnostic ultrasound systems for broad hospital and clinic applications; K242005 adds transesophageal use,...
PIUR Imaging GmbH
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Canon Medical Systems Corporation
Aplio i900, i800, and i700 software V7.0 are mobile multi-region diagnostic ultrasound systems for trained physicians or legally qualified users; the submission adds deep-learning...
Diagnoly
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
See-Mode Technologies Pte. Ltd.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Sonic Incytes
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
EchoNous, Inc.
Kosmos provides point-of-care ultrasound, synchronized ECG, and digital auscultation across cardiac, lung, abdominal, vascular, musculoskeletal, and interventional applications,...
Exo Imaging
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions, USA, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Clarius Mobile Health Corp.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
DiA Imaging Analysis Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Sonio
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
InVision Medical Technology Corporation
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Eko.ai Pte. Ltd d/b/a Us2.ai
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Edgecare Inc.
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Canon Medical Systems Corporation
Aplio i900, i800, and i700 software V8.1 are mobile diagnostic ultrasound systems for trained physicians or legally qualified users across multi-region diagnostic applications; on...
Butterfly Network, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison CO., LTD.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Esaote S.p.A.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Exo Inc
Exo AI Platform AIP001 processes imported adult ultrasound DICOM images for lung A-line and B-line assessment and cardiac ejection-fraction measurement and reporting.
Clarius Mobile Health Corp.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ E10 is a general-purpose diagnostic ultrasound system for broad adult and pediatric applications; K231966 adds AI-assisted renal measurements, anatomy-based preset and color...
GE Medical Systems Ultrasound and Primary Care Diagnostic
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Siemens Medical Solutions USA, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound
Lumify is a general-purpose ultrasound system using compatible Android devices and USB transducers; K232500 adds AI-assisted automatic ejection-fraction quantification.
BK Medical Aps
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Clarius Mobile Health Corp.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Sonio
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Exo Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Ultrasound
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison CO., LTD.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Sonic Incytes
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
BK Medical Aps
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Butterfly Network, Inc.
Butterfly iQ and iQ+ are handheld general-purpose ultrasound systems for adult and pediatric imaging; K220068 adds lung imaging, spectral pulsed-wave Doppler, and an Auto B-line...
Caption Health, Inc
Quantification/measurement
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
DiA Imaging Analysis Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Clarius Mobile Health Corp.
Clarius AI semi-automatically places calipers for non-invasive measurements of musculoskeletal structures on ultrasound data acquired by the Clarius Ultrasound Scanner.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Dyad Medical, Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Vivid iq is compact cardiac and general ultrasound; this release adds thoracic and pleural applications, new transducers, and AI-assisted Easy Auto EF and Easy AFI LV functions.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems
Venue is a mobile point-of-care diagnostic ultrasound system for broad hospital and clinic applications; K220851 adds adult cNerve scouting support, pediatric B-line and real-time...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Venue Go is a point-of-care diagnostic ultrasound system for trained users across broad adult, pediatric, and neonatal applications in hospital and clinical environments.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., LTD
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Canon Medical Systems Corporation
Aplio a550, Aplio a450, and Aplio a software V6.5 are mobile diagnostic ultrasound systems for trained physicians or legally qualified users to visualize structures and dynamic...
GE Healthcare
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Canon Medical Systems Corporation
Aplio i900/i800/i700 software V6.5 is a mobile diagnostic ultrasound system for trained physicians or legally qualified users to visualize structures and dynamic processes and...
Caption Health
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Cycle Clarity
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Healthcare
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA TTA2.50 analyzes ultrasound to quantify and report cardiovascular, fetal, and abdominal structures and functions, including editable AI-assisted echocardiographic...
TaiHao Medical Inc.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Ultromics Limited
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Koios Medical, Inc.
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
DiA Imaging Analysis Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
The TEX20, TEX10, TE X, and TE X Lite family provides mobile diagnostic ultrasound across broad adult, obstetric, pediatric, and neonatal applications; K212265 includes AI-based...
Clarius Mobile Health Corp.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Medical Systems
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison Co., Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
AmCad BioMed Corporation
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Medical Systems
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Samsung Medison CO., LTD.
Samsung V8 is a general diagnostic ultrasound system for broad hospital, clinic, and practice applications; K211945 adds thoracic scanning, AI-based NerveTrack, and AI-based...
EchoNous, Inc.
Kosmos is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can...
eko.ai Pte. Ltd. d/b/a Us2.ai
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Samsung Medison CO., LTD.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
MEDO DX Pte. Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ultromics Ltd
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
DiA Imaging Analysis Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Caption Health
FDA product code QJU identifies this device class as Image Acquisition And/Or Optimization Guided By Artificial Intelligence. A radiological acquisition and/or optimization...
See-Mode Technologies Pte. Ltd.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and
Vivid iq is compact cardiovascular and shared-service ultrasound for cardiac, vascular, abdominal, obstetric, pediatric, and procedure-guidance applications.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and
Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded...
Caption Health
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Medo.ai
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Butterfly Network, Inc.
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Healthcare
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Ultrasound, Inc.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Caption Health
FDA product code QJU identifies this device class as Image Acquisition And/Or Optimization Guided By Artificial Intelligence. A radiological acquisition and/or optimization...
EchoNous, Inc.
KOSMOS combines general-purpose ultrasound with synchronized three-lead single-channel ECG and digital auscultation for adult and pediatric cardiac, lung, abdominal, vascular, and...
Tissue Differentiation Intelligence, LLC
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Philips Healthcare
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ultromics Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Clarius Mobile Health Corp.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
AmCad BioMed Corporation
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
EchoNous, Inc.
FDA product code IYO identifies this device class as System, Imaging, Pulsed Echo, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Bay Labs, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Ventripoint Diagnostics, Ltd.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
Clarius Mobile Health Corp.
FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems Ultrasound and Primary Care Diagnostics
Venue is a mobile point-of-care diagnostic ultrasound system for broad adult and pediatric applications in emergency, critical-care, office, clinic, and hospital settings; K180599...
Verathon Incorporated
BladderScan PRIME PLUS system Transducer: N/A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N = new indication; P = previously...
Clarius Mobile Health Corp.
DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) BM Color...
Siemens Medical Solutions, USA, Inc.
syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange...
SmartTarget, Ltd.
SmartTarget supports image-guided prostate procedures by enhancing two-dimensional transrectal ultrasound images and reconstructing digitized ultrasound video into a...
AmCad BioMed Corporation
It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for.
ClearView Diagnostics Inc.
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.
Clarius Mobile Health Corp.
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3)
QView Medical, Inc.
QVCAD assists readers during breast screening by searching three-dimensional images from an Automated Breast Ultrasound System for mammography-occult lesions in regions without...
DIACARDIO, LTD.
LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...