Use case
A buyer-oriented shortlist for ultrasound workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Philips Ultrasound, LLC
Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...
ROPCA ApS
Supervised automatic ultrasound image acquisition of hand and wrist joints in adults being investigated or monitored for musculoskeletal disease.
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia, Select, Origin, and Origin ICE diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, pediatric, neonatal, cephalic, small-part,...
Anumana, Inc.
WatchMate Software v1.2.0 processes transesophageal echocardiography data to reconstruct the left atrial appendage and assist preprocedural planning and device sizing during...
Sonio
Concurrent physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.
Deski
Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require...
Philips Ultrasound, LLC
EPIQ diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...
Philips Ultrasound, LLC
EPIQ and Affiniti ultrasound systems acquire and display the labeled diagnostic ultrasound and fluid-flow information across fetal, abdominal, cardiac, cephalic, obstetric,...
Wuhan United Imaging Healthcare Co.,Ltd
uSONIQUE Nova, Vita, and Grace series diagnostic ultrasound systems acquire and display the labeled whole-body, abdominal, renal, gynecologic, obstetric, pediatric, cranial,...
Smart Alfa Teknoloji San. Ve Tic. A.S.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Wuhan United Imaging Healthcare Co.,Ltd
uSONIQUE Genesis, Pulse, and Venus variants are diagnostic ultrasound systems for the labeled whole-body, fetal, obstetric, abdominal, pediatric, cranial, cardiac, vascular,...
Philips Ultrasound, LLC
Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling
Mim Fertility
Semi-automatic ovarian follicle count and size assessment from transvaginal ultrasound, with clinician verification before clinical use.
Edgecare, Inc.
EdgeFlow UW20 is a wearable ultrasound system for noninvasive periodic bladder-volume measurement in adults with BMI no greater than 30.
Esaote, S.p.A.
Esaote 6450 Ultrasound for MyLabE80 and MyLabE85 acquires, displays, and analyzes diagnostic ultrasound data for the labeled cardiac, vascular, general, and women's-health...
Butterfly Network, Inc.
Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow;...
Philips Ultrasound, LLC
EPIQ and Affiniti diagnostic ultrasound systems provide the labeled abdominal, cardiac, fetal, pediatric, vascular, cephalic, gynecologic, musculoskeletal, small-organ, urologic,...
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
LOGIQ Vita and S20 are general-purpose diagnostic ultrasound systems for fetal and obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, peripheral-vascular,...
Sonio
Sonio Detect v3 analyzes fetal ultrasound images and clips to detect views and anatomical structures and to check labeled image-quality characteristics during acquisition or...
QT Imaging Holdings, Inc.
QT Scanner 2000 Model A uses ultrasonic reflection and transmission imaging to calculate fibroglandular tissue volume and the fibroglandular-tissue-to-total-breast-volume ratio in...
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
Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the...
Ultrasound AI
Delivery Date AI analyzes obstetric ultrasound images to provide a predicted delivery date for singleton pregnancies in women age 18 or older at 14 0/7 through 36 6/7 weeks when...
GE Medical Systems Ultrasound and Primary Care Diagnostics
LOGIQ Totus is a general-purpose diagnostic ultrasound system for the labeled fetal, obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal,...
GE Medical Systems Ultrasound and Primary Care Diagnostics
LOGIQ Fortis is a general-purpose diagnostic ultrasound system for the labeled fetal, obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal,...
Samsung Medison Co., Ltd.
HERA Z20 and the labeled Samsung ultrasound systems acquire and analyze diagnostic ultrasound images and body-fluid information across the labeled adult, pediatric, fetal,...
Bioticsai, Inc.
BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating...
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.
PVAD IQ supports qualified-physician clinical decision support by identifying the aortic annulus and PVAD inlet, calculating their mean distance, and identifying clips acceptable...
Ultrasight, Ltd.
UltraSight Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals other than expert sonographers in...
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.
The 7600 Ultrasound System provides multifunctional diagnostic ultrasound imaging, analysis, Doppler, elastography, three-dimensional and four-dimensional imaging, and...
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Voluson Expert 18, 20, and 22 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, gynecologic, abdominal,...
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
LOGIQ E10s is a general-purpose diagnostic ultrasound system supporting the labeled adult, pediatric, cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal,...
Ge Medical Systems Ultrasound and Primary Care Diagnostics
LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular,...
X9, Inc.
X9 Ultrasound System provides ultrasound imaging of validated vascular access for hemodialysis during the preliminary stage before needle insertion; a qualified healthcare...
Philips Ultrasound, LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow assessment across the labeled adult, pediatric, fetal, cardiac, vascular, abdominal, small-organ,...
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
FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...
Fujifilm Sonosite Inc
Sonosite LX and PX ultrasound systems acquire, display, analyze, and support needle guidance for the labeled general, cardiac, vascular, abdominal, obstetric, and procedural...
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia, Select, Origin, and Origin ICE are multipurpose diagnostic ultrasound systems for the labeled fetal, abdominal, pediatric, cephalic, cardiac, vascular,...
GE Medical Systems Ultrasound and Primary care Diagnostics
Venue, Venue Go, Venue Fit, and Venue Sprint are general-purpose point-of-care ultrasound systems for trained users across broad adult, pediatric, and neonatal applications, with...
Philips Ultrasound LLC
EPIQ and Affiniti diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, cardiac, cephalic, obstetric, musculoskeletal, vascular, small-organ, and...
Samsung Medison Co., Ltd.
The Samsung V-family diagnostic ultrasound systems support fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, thoracic, vascular,...
GE Medical Systems Ultrasound and Primary Care Diagnostics
EchoPAC Software Only and Plug-in provide diagnostic review, analysis, recording, and reporting functions for ultrasound images, including raw GE and DICOM ultrasound data.
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid Pioneer is a general-purpose ultrasound system with the labeled adult and pediatric cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal, urologic,...
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.
The 6600 Ultrasound System is a multifunctional diagnostic ultrasound scanner that collects, displays, and analyzes ultrasound images during ultrasound imaging procedures with...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
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
Voluson Performance 16 and 18 are general-purpose diagnostic ultrasound systems for imaging, measurement, display, and analysis of the human body and fluid across the labeled...
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
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
Esaote S.p.A.
The 6450 Ultrasound System is a multifunctional diagnostic ultrasound scanner for collecting, displaying, and analyzing ultrasound images with supported probes; Virtual Navigator...
Philips Ultrasound LLC
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
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 deep-learning automatic bladder-volume...
Canon Medical Systems Corporation
UltraExtend NX allows a user to observe images and perform analysis based on examination data from the named diagnostic ultrasound systems in hospital and clinical settings by...
Exo Inc
Lung AI LAI001 assists trained healthcare professionals performing point-of-care lung ultrasound by detecting and visualizing pleural effusion and consolidation or atelectasis in...
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
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
Deski
HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live...
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....
Ventripoint Diagnostics Ltd.
Ventripoint VMS+ 4.0 is an adjunct to an existing ultrasound system that records, analyzes, stores, and retrieves digital ultrasound images for computerized three-dimensional...
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.
The V8/cV8, V7/cV7, and V6/cV6 diagnostic ultrasound systems and probes obtain ultrasound images and analyze body fluids across the labeled fetal, obstetric, abdominal,...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid iq is a compact Track 3 general-purpose diagnostic ultrasound system for trained healthcare professionals, with labeled cardiac, vascular, abdominal, obstetric, small-organ,...
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
EPIQ and Affiniti are diagnostic ultrasound systems for imaging and fluid-flow analysis of the human body across the labeled abdominal, cardiac, vascular, fetal, gynecologic,...
Sonoscape Medical Corp.
The P60 is a general-purpose ultrasonic imaging system for trained healthcare professionals in hospitals across the labeled fetal, obstetric, abdominal, pediatric, small-organ,...
Caption Health, Inc.
Cardiac Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images. It is...
GE Medical Systems Ultrasound and Primary care Diagnostics
The Voluson Expert 18, 20, and 22 are general-purpose ultrasound systems for qualified and trained healthcare professionals. The FDA material describes fetal and obstetric,...
Philips Ultrasound LLC
The EPIQ and Affiniti systems are intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA indication lists abdominal, adult, fetal and...
Samsung Medison Co., Ltd.
The Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by...
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.
The HERA W10 and HERA W9 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The FDA indication lists fetal and obstetric,...
Exo Inc
Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept...
Siemens Medical Solutions USA, Inc.
The ACUSON Sequoia and Sequoia Select systems provide images or signals from inside the body for fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...
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
The 5000 Compact ultrasound systems are intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA indication lists abdominal, adult and...
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.
The HERA Z20, R20, Z30, and R30 systems and transducers are intended for diagnostic ultrasound imaging and analysis of body fluids. The FDA material lists fetal and obstetric,...
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
The EPIQ ultrasound diagnostic system is intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA material lists abdominal, adult, fetal and...
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
PIUR tUS Infinity supports a computer-aided thyroid ultrasound workflow that identifies thyroid lobes and margins, calculates volume, marks and quantifies nodules, and provides...
Canon Medical Systems Corporation
Aplio i900/i800/i700 V7.0 is a mobile diagnostic ultrasound system with supported body and cardiac clinical applications and imaging modes for trained physicians and legally...
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
Velacur Sonic measures liver tissue stiffness, ultrasound attenuation, and volume density fat fraction with shear-wave and ultrasound measurements to aid clinical management of...
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....
Aisap
AISAP CARDIO V1.0 automatically processes and analyzes acquired cardiac POCUS images and produces a report with diagnostic assessment and measurements, including selected valvular...
Siemens Medical Solutions, USA, Inc.
The ACUSON systems are intended to provide images or signals from inside the body by appropriately trained healthcare professionals in clinical settings for fetal, abdominal,...
Samsung Medison Co., Ltd.
The Samsung V8, XV8, XH8, V7, XV7, XH7, V6, XV6, XH6 diagnostic ultrasound systems provide general diagnostic ultrasound and fluid-flow analysis across fetal, obstetric,...
Clarius Mobile Health Corp.
Clarius OB AI assists a trained and qualified healthcare professional with measurements of fetal biometric parameters, including head circumference, abdominal circumference, femur...
Samsung Medison Co., Ltd.
The RS85 diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids. The FDA indication lists fetal and obstetric, abdominal, gynecologic,...
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
The EPIQ and Affiniti systems are intended for diagnostic ultrasound imaging and fluid-flow analysis of the human body. The FDA material lists adult, fetal and pediatric cardiac,...
Eko.ai Pte. Ltd d/b/a Us2.ai
Us2.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and...
GE Medical Systems Ultrasound and Primary care Diagnostics
The Voluson Signature 18 and 20 are general-purpose diagnostic ultrasound systems with specialized OB/GYN use. The FDA material describes fetal and obstetric, abdominal,...
Edgecare Inc.
EdgeFlow UH10 is an ultrasound device intended to measure urine volume in the bladder noninvasively in professional healthcare facilities such as hospitals and clinics by...
Philips Ultrasound LLC
EPIQ and Affiniti diagnostic ultrasound systems provide diagnostic ultrasound imaging and fluid-flow analysis across the labeled adult, pediatric, obstetric, cardiac, vascular,...
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.
Butterfly iQ3 is a general-purpose portable ultrasound system for adult and pediatric imaging, peripheral vessels, small organs, breast, thyroid, scrotum, cardiac, abdominal,...
Samsung Medison CO., LTD.
The HM70 EVO diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids for the listed fetal, obstetric, abdominal, gynecologic, pediatric,...
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ Totus is a general-purpose diagnostic ultrasound system for trained healthcare professionals to image, measure, display, and analyze the human body and fluid across the...
Philips Ultrasound LLC
EPIQ Series Diagnostic Ultrasound System provides diagnostic ultrasound imaging and fluid-flow analysis across the labeled clinical applications; exact probes, modes, anatomies,...
Esaote S.p.A.
6440 MyLabX90 is a general-purpose diagnostic ultrasound system for labeled imaging and fluid-flow applications; exact probes, modes, anatomies, and patient populations require...
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
LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems for trained healthcare professionals to image, measure, display, and analyze the human body and fluid...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Voluson Expert 22, Expert 20, and Expert 18 are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals across the labeled...
Siemens Medical Solutions USA, Inc.
The ACUSON Sequoia and Sequoia Select systems provide ultrasound images or signals for the labeled fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...
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
Ultrasound System 1300 is a diagnostic ultrasound system for the labeled clinical applications, probes, modes, and patient populations; the exact scope must be confirmed from the...
Ontact Health Co., Ltd.
Sonix Health quantifies and reports adult echocardiography by or on the order of a licensed physician using B-mode, M-mode, pulsed-wave Doppler, and continuous-wave Doppler images.
Clarius Mobile Health Corp.
The Clarius Ultrasound Scanner is a software-based, transportable ultrasound imaging system for diagnostic ultrasound imaging and fluid-flow analysis across the labeled...
Samsung Medison Co., Ltd.
The V8/H8, V7/H7, and V6/H6 diagnostic ultrasound systems and transducers obtain ultrasound images and analyze body fluids across the labeled fetal, abdominal, gynecologic,...
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.
UltraSight Inc.
UltraSight AI Guidance assists non-expert healthcare professionals with acquisition of ten standard adult two-dimensional transthoracic echocardiography views by providing...
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
Voluson SWIFT and Voluson SWIFT+ are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals to image, measure, display, and analyze the...
Philips Ultrasound LLC
The K231190 EPIQ submission adds the mL26-8 linear-array transducer for labeled high-resolution superficial, musculoskeletal, ophthalmic, pediatric, peripheral-vessel, breast,...
Philips Ultrasound
Lumify acquires diagnostic ultrasound data in labeled B, color, combined, pulsed-wave Doppler, and M modes for fetal, obstetric, abdominal, pediatric, cephalic, urologic,...
Samsung Medison CO., LTD.
The HERA W9 and HERA W10 diagnostic ultrasound systems and transducers provide diagnostic ultrasound imaging and fluid analysis across the labeled fetal, abdominal, gynecologic,...
Sonic Incytes
Velacur Sonic measures liver tissue stiffness and ultrasound attenuation to aid clinical management of liver disease within the labeled workflow.
BK Medical Aps
Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative,...
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.
The V8 and V7 diagnostic ultrasound systems and probes obtain ultrasound images and analyze body fluids across the labeled fetal, abdominal, gynecologic, intraoperative,...
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.
HS40 is a general-purpose diagnostic ultrasound system for imaging and analysis of body fluids in fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic,...
GE Medical Systems Ultrasound and
Vivid E80, Vivid E90, and Vivid E95 are general-purpose diagnostic ultrasound systems with specialized cardiac applications for imaging, measurement, display, and analysis across...
GE Medical Systems Ultrasound and Primary Care Diagnostics
EchoPAC Software Only and EchoPAC Plug-in review and analyze supported GE ultrasound raw data and DICOM ultrasound images, manage patient records, and support reporting for the...
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
Vivid T8 and Vivid T9 are general-purpose diagnostic ultrasound systems with specialized cardiac applications for fetal, abdominal, pediatric, small-organ, cephalic, cardiac,...
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
Vivid S60N and Vivid S70N are general-purpose cardiac diagnostic ultrasound systems supporting adult and pediatric echocardiography and labeled thoracic or pleural ultrasound...
Samsung Medison Co., Ltd.
V8 and V7 Diagnostic Ultrasound Systems obtain ultrasound images and analyze body fluids for fetal, obstetric, abdominal, gynecologic, intraoperative, pediatric, small-organ,...
GE Medical Systems
Venue Fit is a general-purpose diagnostic ultrasound system for trained healthcare professionals across labeled abdominal, thoracic, cardiac, vascular, obstetric, pediatric,...
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
Voluson Expert 18, Voluson Expert 20, and Voluson Expert 22 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal,...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Balance is a general-purpose diagnostic ultrasound system for imaging, measurement, display, and analysis of the human body and body fluids across the labeled fetal,...
Samsung Medison Co., LTD
HERA W10 and HERA W9 Diagnostic Ultrasound Systems obtain ultrasound images and analyze body fluids for the labeled fetal, obstetric, abdominal, gynecologic, pediatric,...
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
Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, abdominal, gynecologic,...
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
Voluson S6, S8, S8t, S10, and S10 Expert are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, abdominal,...
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.
Clarius Ultrasound Scanner is a general-purpose diagnostic ultrasound system for trained healthcare professionals across the labeled fetal, abdominal, pelvic, small-organ,...
Philips Medical Systems
Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are general-purpose diagnostic ultrasound systems for imaging and analysis across the labeled fetal, abdominal, pelvic,...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Premier is a general diagnostic ultrasound system for fetal and obstetric, abdominal, gynecologic, urologic, pediatric, small-organ, cardiac, vascular, musculoskeletal,...
Samsung Medison Co., Ltd.
HERA W9 and HERA W10 Diagnostic Ultrasound Systems obtain ultrasound images and analyze body fluids across the labeled fetal, obstetric, abdominal, gynecologic, pediatric,...
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
EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems are general-purpose diagnostic ultrasound systems for the labeled fetal, abdominal, pelvic, small-organ, cephalic,...
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.
HS40 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system for imaging and analysis of body fluids across the labeled fetal, abdominal, pelvic,...
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....
DiA Imaging Analysis Ltd
LVivo Software Application non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients...
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
LVivo Seamless non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with...
GE Medical Systems Ultrasound and Primary Care Diagnostics
EchoPAC Software Only and EchoPAC Plug-in are intended for diagnostic review and analysis of ultrasound images, patient-record management, and reporting for use by or on the order...
Caption Health
Caption Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images. It is...
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
Vivid T8 and Vivid T9 are general-purpose ultrasound systems specialized for cardiac imaging and intended for qualified and trained healthcare professionals for ultrasound...
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and...
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
Caption Interpretation Automated Ejection Fraction Software processes previously acquired adult transthoracic cardiac ultrasound images, stores and manipulates images, and...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid S60N and Vivid S70N are general-purpose cardiac diagnostic ultrasound systems supporting adult and pediatric echocardiography and the labeled thoracic or pleural ultrasound...
DiA Imaging Analysis Ltd
LVivo Software Application processes ultrasound clips and supports the labeled LVivo EF, SG, SAX, RV, and Bladder measurements and analyses, with user review and editing of...
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
QLAB Advanced Quantification Software is a software application package designed to view and quantify image data acquired on Philips ultrasound systems.
Philips Ultrasound, Inc.
The K201012 labeling covers Philips EPIQ, Affiniti, CX50, Sparq, and Lumify diagnostic ultrasound systems plus QLAB image viewing and quantification across labeled adult,...
Caption Health
Caption Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images. It is...
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
The SonoVision Ultrasound Imaging System is a general-purpose ultrasound system intended for use by a qualified physician for visualization and evaluation of nerves, vascular, and...
Philips Healthcare
QLAB Advanced Quantification Software views and quantifies image data acquired on Philips ultrasound systems for professional review, including supported three-dimensional cardiac...
Ultromics Ltd
EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician...
Ventripoint Diagnostics, Ltd.
VMS+ 3.0 is an adjunct to existing ultrasound imaging systems intended to record, analyze, store, and retrieve digital ultrasound images for computerized three-dimensional image...
Clarius Mobile Health Corp.
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and...
AmCad BioMed Corporation
AmCAD-UO analyzes pharyngeal and upper-airway ultrasonic images to visualize and quantify airway structures for physician evaluation and monitoring.
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid E80, Vivid E90, and Vivid E95 are general-purpose ultrasound systems specialized for cardiac imaging and intended for use by or under the direction of a qualified physician...
EchoNous, Inc.
Uscan is a diagnostic ultrasound system for abdominal, musculoskeletal, pediatric, small-organ, and peripheral-vessel imaging by trained users.
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.
VMS+ is an adjunct to existing ultrasound imaging systems intended to record, analyze, store, and retrieve digital ultrasound images for computerized three-dimensional image...
Clarius Mobile Health Corp.
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and...
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 is a diagnostic ultrasound system with a bladder indication for noninvasive measurement of urine volume in the bladder using the supported probe and device...
Clarius Mobile Health Corp.
Clarius Ultrasound Scanner is a software-based diagnostic ultrasound imaging system for trained healthcare professionals across labeled abdominal, thoracic, musculoskeletal,...
SmartTarget, Ltd.
SmartTarget is an accessory for image-guided interventional and diagnostic prostate procedures that enhances two-dimensional transrectal ultrasound, reconstructs three-dimensional...
AmCad BioMed Corporation
AmCAD-UV classifies ultrasonic color-intensity data and lets users view primary pulsatile, secondary pulsatile, and unidentified signals in flow-Doppler ultrasound images. It is a...
ClearView Diagnostics Inc.
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.
Clarius Mobile Health Corp.
The Clarius Ultrasound System is a software-based ultrasound imaging system and accessories for point-of-care imaging of medical conditions, including emergency triage for trauma,...
QView Medical, Inc.
The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System,...
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...