Use case
A buyer-oriented shortlist for cardiac imaging. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Adas3D Medical S.L.
ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...
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,...
Siemens Medical Solutions USA, Inc.
An extension for syngo.via that assists trained physicians with automated and semi-automated analysis, visualization and reporting of cardiac CT angiography volume datasets for...
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...
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA
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,...
Canon Medical Informatics, Inc.
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 Nova, Vita, and Grace series diagnostic ultrasound systems acquire and display the labeled whole-body, abdominal, renal, gynecologic, obstetric, pediatric, cranial,...
Canon Medical Systems Corporation
Canon Aquilion ONE V2.0 acquires and processes whole-body CT volumes, including head, chest, abdomen, pelvis, cardiac, extremity, inner-ear, and multi-energy examinations with the...
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
ABBOTT MEDICAL
Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR provides viewing, manipulation, evaluation, and analysis of MR images, including labeled breast, brain, perfusion, vessel, cardiac, diffusion, susceptibility,...
Siemens Healthcare GmbH
syngo Dynamics VA41F is a vendor-agnostic cardiology image and information-management system that supports multimodality review, diagnosis, and patient management for the labeled...
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...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo variants acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, attenuation correction, and the labeled...
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...
Shimadzu Corporation
Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational,...
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,...
Ge Medical Systems, LLC
Photonova Spectra and Spectra Select are silicon-based spectral photon-counting detector CT systems that acquire cross-sectional body images, multienergy data, monochromatic...
Philips Medical Systems Nederland B.V.
EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.
Canon Medical Systems Corporation
Aquilion Serve SP V2.0 acquires and displays cross-sectional whole-body CT volumes, with labeled AiCE, PIQE, and CLEAR Motion image-processing functions for supported examinations.
Canon Medical Systems Corporation
Alphenix and INFX-8000V/B,S V9.6 with aEvolve FOV Extension are digital radiography and fluoroscopy systems for diagnostic and interventional angiography, with labeled real-time...
Philips Medical Systems Nederland B.V.
AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac...
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...
Cara Medical, Ltd.
CARA assists adult structural-heart and conduction-system procedure planning by segmenting preprocedural CT, visualizing cardiac chambers and conduction landmarks, and overlaying...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo PET/CT acquires anatomical CT and functional PET images of radiopharmaceutical distribution for qualified diagnostic and treatment-planning workflows, including...
Ai4medimaging Medical Solutions S.A.
Cardiac MRI ventricular function and 2D phase-contrast flow quantification
Siemens Medical Solutions USA, Inc.
MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time...
Ge Medical Systems, LLC
SIGNA Bolt is a whole-body MRI system for high-resolution diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol...
Ge Medical Systems, LLC
SIGNA Sprint Select is a whole-body MRI system for diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol functions.
Shanghai United Imaging Healthcare Co., Ltd.
uCT 780 acquires cross-sectional whole-body CT images, including head, neck, cardiac, and vascular examinations, with labeled low-dose lung-cancer-screening use and uWS-CT-Dual...
Qure.Ai Technologies
qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...
Softlink International Private Limited
Imagine Enterprise Suite receives, stores, shares, visualizes, quantifies, and processes images from multiple modalities; MPXA-2000 supports coronary-angiography calculation with...
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,...
Spectrum Dynamics Medical, Ltd.
TruSPECT Processing Station receives, transfers, displays, stores, and processes radioisotope-tracer images for trained professionals; TruClear AI SPECT enhancement supports the...
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
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...
Canon Medical Systems Corporation
Cartesion Prime PET/CT acquires cross-sectional CT images and PET radiopharmaceutical-distribution images and includes AiCE-i PET processing and a neural-network...
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,...
Pie Medical Imaging BV
3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray...
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,...
Circle Cardiovascular Imaging, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Spectrawave, Inc.
SpectraWAVE X1-FFR Software segments coronary vessels and reports vessel dimensions, stenosis quantification, and pressure-drop estimates under the supervision of a cardiologist.
Canon Medical Systems Corporation
Alphenix V9.6 with aEvolve Imaging is a digital radiography and fluoroscopy system for diagnostic and interventional angiography of the labeled vessels, with AI Denoising and MFP...
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,...
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...
GE Medical Systems, LLC
SIGNA Sprint is a 1.5T whole-body MRI system for diagnostic imaging of the labeled head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and...
Angiowave Imaging, Inc.
AngioWaveNet aids qualified physicians in analyzing and interpreting X-ray coronary angiographic cine images in adults by enhancing visibility of blood vessels, vascular...
Careverse Technology 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....
Nurea
PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images;...
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...
Vista AI, Inc.
Vista OS, Vista AI Scan, and RTHawk operate as accessories with compatible GE and Siemens 1.5T and 3T MR systems to acquire, reconstruct, display, and support technologist...
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,...
Artrya Limited
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, LLC
Revolution Vibe is a general-purpose and cardiac-optimized CT system for head, whole-body, cardiac, and vascular imaging across the labeled age range.
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,...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo and Panvivo S acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, and the labeled oncology, cardiology,...
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,...
Caranx Medical
TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.
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,...
GE Medical Systems, LLC
Sonic DL is optional integrated GE MRI reconstruction for supported 2D cardiac cine and 3D fast-spin-echo or gradient-echo acquisitions at 1.5T, 3T, and 7T for all ages and...
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...
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...
Shanghai United Imaging Healthcare Co.,Ltd.
uCT ATLAS Astound and uCT ATLAS are whole-body CT systems for head, body, cardiac, and vascular imaging, with dual-energy analysis options and protocol-governed low-dose...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...
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....
Shanghai United Imaging Healthcare Co.,Ltd.
uAngio AVIVA CX provides image guidance for diagnostic, interventional, and surgical procedures, including cardiac, neuro, vascular, nonvascular, rotational angiography, and...
LARALAB GmbH
Cardiac CT segmentation, measurement and valve-intervention planning
Arineta Ltd.
SpotLight and Duo produce cross-sectional images from X-ray transmission data for cardiovascular and thoracic examinations, including heart imaging with or without contrast and a...
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...
QFR Solutions bv
FDA product code QHA identifies this device class as X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device. X-ray angiographic imaging based coronary...
Siemens Healthcare GmbH
syngo Dynamics VA41D is a multimodality, vendor-agnostic cardiology image and information system for management, processing, review, post-processing, and quantification of cardiac...
TribusMed Beheer BV
TribusConnect provides remote viewing and manipulation of CT DICOM data for pre- and post-cardiac-intervention review, including volume rendering, heart segmentation, simulated...
Coreline Soft Co., Ltd.
AVIEW assists physicians with quantitative CT analysis of thoracic and cardiac datasets, including lung, lobe, airway, fissure, nodule, coronary calcium, density, measurement, and...
GE Medical Systems, LLC
SIGNA Prime Elite is a whole-body MR system that produces cross-sectional, spectroscopic, parametric, and dynamic images of the labeled body regions for trained physician...
Cleerly, Inc.
Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
Phantomics Inc.
Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including...
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...
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...
Shanghai United Imaging Healthcare Co., Ltd.
uCT 550 is a CT X-ray system that produces cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including...
Shanghai United Imaging Healthcare Co., Ltd.
uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and...
Canon Medical Systems Corporation
Aquilion ONE (TSX-308A/3) V1.5 acquires and displays cross-sectional volumes of the whole body, including the head, with the capability to image whole organs in a single rotation....
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...
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,...
Mycardium AI Limited
1CMR Pro displays, analyzes, and transfers DICOM cardiovascular images acquired in CMR scanners, including multi-slice, multi-phase, multi-parametric, and velocity-encoded CMR...
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...
TeraRecon,Inc.
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 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,...
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...
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.
Adas3D Medical S.L
ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for...
Shanghai United Imaging Intelligence Co., Ltd.
uAI Portal is a software solution for viewing, manipulating, communicating, and storing medical images and for supporting interpretation and evaluation in healthcare institutions....
EchoNous, Inc.
Kosmos provides point-of-care ultrasound, synchronized ECG, and digital auscultation across cardiac, lung, abdominal, vascular, musculoskeletal, and interventional applications,...
GE Medical Systems Israel, Functional Imaging
Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone,...
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,...
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,...
Circle Cardiovascular Imaging
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...
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,...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR is a software solution for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists MR stitching,...
Canon Medical Systems Corporation
The Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System acquires and displays cross-sectional volumes of the whole body, including the head, with whole-organ imaging in...
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,...
inHEART, SAS
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Hangwei Medical Systems Co., Ltd.
Revolution Ascend Sliding produces cross-sectional images by computer reconstruction of X-ray transmission data, including axial, cine, helical, cardiac, and gated acquisitions,...
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,...
GE Healthcare (Tianjin) Company Limited
The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra,...
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,...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MI is software for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images within healthcare institutions, with labeled applications for...
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...
Circle Cardiovascular Imaging
Myocardial Strain Software Application provides qualitative and quantitative evaluation of cardiovascular MR images, including two-dimensional displacement, velocity, strain,...
Canon Medical Systems Corporation
The Aquilion Serve SP (TSX-307B/1) V1.3 acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using...
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.
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,...
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.
Arineta Ltd.
SpotLight and SpotLight Duo are dedicated cardiovascular and thoracic CT systems; K230370 adds optional deep-learning image reconstruction for patients older than 2 years to...
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,...
Canon Medical Systems Corporation
The Aquilion Serve acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
UltraSight Inc.
UltraSight AI Guidance assists non-expert healthcare professionals with acquisition of ten standard adult two-dimensional transthoracic echocardiography views by providing...
FUJIFILM Healthcare Corporation
The ECHELON Synergy MRI system is a 1.5T MR imaging device that provides non-ionizing physiological and clinical information and produces transverse, coronal, sagittal, oblique,...
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...
FEops nv
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,LLC (GE Healthcare)
Sonic DL is deep-learning MRI reconstruction for highly undersampled or accelerated cardiac acquisitions on compatible GE 1.5T and 3.0T MRI systems for pediatric and adult...
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,...
GE Healthcare Japan Corporation
Deep Learning Image Reconstruction is a deep-learning reconstruction method that produces cross-sectional images of the head and whole body from X-ray transmission data acquired...
BK Medical Aps
Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative,...
Canon Medical Systems Corporation
The Aquilion Precision acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
Canon Medical Systems Corporation
The Aquilion Serve acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
GE Healthcare
The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...
Shanghai United Imaging Healthcare Co., Ltd.
uCT ATLAS Astound is a computed-tomography X-ray system that produces cross-sectional images of the whole body and is applicable to head, whole-body, cardiac, and vascular CT; it...
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,...
GE Healthcare (Tianjin) Company Limited
SIGNA Victor is a whole-body magnetic-resonance scanner for high-resolution imaging, high signal-to-noise ratio, and short scan times. It is indicated to produce axial, sagittal,...
Coreline Soft Co.,Ltd.
AVIEW provides quantitative CT analysis of pulmonary and cardiac anatomy, including lung, lobe, airway, fissure, nodule, coronary calcium, and related measurements and reports to...
Philips Healthcare (Suzhou) Co., Ltd
The Philips CT 3500 produces CT images of the head and body and is indicated for head, whole-body, cardiac-calcium-scoring, and vascular CT in patients of all ages; it is also...
Coreline Soft Co.,Ltd
AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision...
Canon Medical Systems Corporation
Aquilion Precision TSX-304A/4 V10.10 with AiCE is a CT system for cross-sectional imaging of the labeled abdomen, pelvis, chest, cardiac, extremity, and head examinations,...
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,...
Siemens Medical Solutions USA, Inc.
MI View&GO is a multimodality medical-image application for viewing, manipulating, quantifying, analyzing, and comparing PET, SPECT, CT, and MR images across time points in...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on the Discovery CT750 HD...
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...
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,...
Canon Medical Systems Corporation
Aquilion ONE with Vitrea VSTP-001A provides whole-body CT acquisition and reconstruction with labeled FIRST, AiCE, spectral, cardiac, vascular, pulmonary, neurologic, abdominal,...
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,...
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT provides head, whole-body, cardiac, and vascular CT imaging for patients of all ages and can support qualified low-dose lung screening under labeled programs...
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 Medical Systems, LLC.
TrueFidelity deep-learning CT reconstruction supports head, whole-body, cardiac, and vascular imaging on specified Revolution CT configurations with release-specific speed and...
GE Healthcare
Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, abdominal, gynecologic,...
GE Healthcare Japan Corporation
Revolution Ascend produces axial, cine, helical, cardiac, and gated CT images from X-ray transmission data with or without contrast, with post-processing and analysis for head,...
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...
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...
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 Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution Ascend.
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,...
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,...
Spectrum Dynamics Medical Ltd
TruSPECT Radiological Image Processing Station receives, transfers, displays, stores, and processes radioisotope-tracer images for trained professionals in the labeled SPECT...
EchoNous, Inc.
Kosmos is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can...
Siemens Medical Solutions USA, Inc.
syngo.via MI WorkFlows, Scenium, and syngo MBF support the viewing, processing, and quantitative review of supported molecular-imaging and cardiac studies in the exact K211459...
Abbott Medical
OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System acquire, display, and analyze intravascular optical coherence tomography images for trained professionals...
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,...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation, including...
Circle Cardiovascular Imaging Inc.
TruPlan provides CT image processing, visualization, measurements, and cardiac procedure-planning workflow support for the labeled use; exact procedure scope and outputs are...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head. Volume sets may be used for specialized studies by a trained and...
Siemens Medical Solutions USA, Inc.
syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points,...
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...
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...
Coreline Soft Co., Ltd
AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets and supports quantitative diagnosis, follow-up evaluation, and documentation through lung,...
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...
Shanghai United Imaging Healthcare Co., Ltd.
Deep Recon is a data-driven deep-learning CT reconstruction method for axial, helical, and cardiac acquisitions. It is designed to generate lower-noise CT images, improve...
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...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring analyzes noncontrast standard- or low-dose cardiac CT, marks calcified coronary lesions, allocates them to the right coronary, left main, left anterior...
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...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation, including...
Galgo Medical S.L
ADAS 3D post-processes contrast cardiac MRI and CTA to visualize and quantify myocardial scar and export reviewed results to electrophysiology navigation systems; it is not...
Philips Healthcare
QLAB Advanced Quantification Software views and quantifies image data acquired on Philips ultrasound systems for professional review, including supported three-dimensional cardiac...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring analyzes noncontrast cardiac CT, marks and allocates calcified coronary lesions to the right coronary, left main, left anterior descending, or circumflex...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution EVO.
Ultromics Ltd
EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician...
Cleerly Inc
Cleerly Labs provides interactive cardiac CT or CCTA analysis for the presence and extent of coronary plaque, atherosclerosis, and stenosis in coronary artery disease or suspected...
HeartVista, Inc.
FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.
Omega Medical Imaging, LLC
CS-series-FP radiographic and fluoroscopic systems support cardiac, vascular, general, and interventional procedures; FluoroShield provides secondary region-of-interest...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Cardiovascular processes previously acquired CT DICOM studies to support quantitative and qualitative cardiovascular analysis, including heart segmentation and...
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...
TeraRecon 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.
ClariPI Inc.
ClariCT.AI assists radiologists and specialists by denoising and enhancing DICOM CT images of the head, chest, heart, and abdomen, including low-dose filtered-back-projection and...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation. Volume...
GE Medical Systems, LLC.
TrueFidelity deep-learning CT reconstruction produces low, medium, or high-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution CT.
Elucid Bioimaging Inc.
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...
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...
Ziosoft, Inc.
Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with...
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...
Clarius Mobile Health Corp.
Clarius Ultrasound Scanner is a software-based diagnostic ultrasound imaging system for trained healthcare professionals across labeled abdominal, thoracic, musculoskeletal,...
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,...
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...
CIRCLE CARDIOVASCULAR IMAGING INC
cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.