Modality
216 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Siemens Healthineers AG
LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.
Imeka Solutions, Inc.
ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...
Shanghai United Imaging Healthcare Co., Ltd.
uMR Astra is a diagnostic MR system for cross-sectional and spectroscopic imaging of the labeled head, body, and extremities.
Neurophet., Inc.
Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric...
BeauBrain Healthcare, Inc.
Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...
Quantib B.V.
Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
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,...
Smart Soft Healthcare AD
Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for...
Canon Medical Systems Corporation
Vantage Fortian and Orian 1.5T produce diagnostic MR images of the head and body, including labeled noncontrast angiography, for trained technologists and physician interpretation.
Esaote, S.p.A.
S-scan Open is an Esaote MR system for diagnostic image acquisition, reconstruction, display, and professional interpretation within the labeled scanner, coil, sequence, and...
Airs Medical, Inc.
MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.
Perspectum, Ltd.
LiverMultiScan v6.0 is MR diagnostic software for non-invasive liver-health assessment that generates, displays, and supports review of MR data and quantitative cT1, PDFF, and LIC...
Esaote, S.p.A.
Magnifico Open is a general-purpose MRI system that acquires, displays, and analyzes MR images and real-time imaging for the labeled body regions and open-MRI applications.
Philips Medical Systems Nederland B.V.
The Ingenia, Ingenia CX, Elition, Ambition, BlueSeal, MR5300, and MR7700 systems produce diagnostic MR images, spectra, and physical parameters of the head, body, and extremities...
Siemens Shenzhen Magnetic Resonance, Ltd.
MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique images, spectroscopic images and spectra, and labeled information...
Ai4medimaging Medical Solutions S.A.
Cardiac MRI ventricular function and 2D phase-contrast flow quantification
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.
Siemens Healthcare GmbH
Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
Ge Medical Systems, LLC
AIR Recon DL adds a deep-learning phase-correction and reconstruction option to supported GE 1.5T, 3T, and 7T MR workflows for all labeled anatomies and ages to reduce noise or...
TOPIA MEDTECH LIMITED
Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset...
Siemens Healthcare GmbH
The listed MAGNETOM 1.5T and 3T MRI systems produce cross-sectional images, spectroscopic images or spectra, and derived physical parameters of the head, body, and extremities for...
Neosoma, Inc.
Neosoma Brain Mets semi-automatically segments and contours previously diagnosed brain metastases on T1 post-contrast brain MRI to support radiation-oncology treatment planning.
Hyperfine, Inc.
Swoop Portable MR Imaging System provides ultra-low-field point-of-care head MRI for all ages and includes deep-learning T1, T2, FLAIR, and DWI reconstruction.
Siemens Shenzhen Magnetic Resonance, Ltd.
MAGNETOM Free.Max and Free.Star with syngo MR XA80A are 0.55T MRI systems for broad imaging and compatible interventions; this release adds dentomaxillofacial coil and assist...
Imeka Solutions, Inc.
Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical...
Quantib BV
Brain WMH automatically labels, visualizes, and volumetrically quantifies white-matter hyperintensities from T2w FLAIR brain MR and returns segmentations, overlays, and...
Shanghai United Imaging Healthcare Co., Ltd.
uMR 680 is a 1.5T MRI system that produces transverse, sagittal, coronal, oblique, and spectroscopic images and physical parameters of the head, body, and extremities, including...
AIRS Medical Inc.
Adjunctive brain MRI morphometry and lesion-quantification support for qualified healthcare professionals, including segmented overlays, volumetric measurements, normative...
Fujifilm Corporation
ECHELON Synergy is a whole-body MRI system that provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved...
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...
Springbok, Inc. (dba Springbok Analytics)
Automatic MRI segmentation and quantitative analysis of muscle, bone, fat, and other anatomical structures to assist visualization and measurement; not direct disease diagnosis.
Galileo CDS, Inc
Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.
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...
Shanghai United Imaging Healthcare Co., Ltd.
uMR Jupiter is a diagnostic MR system for imaging the labeled head, body, and extremities in patients weighing more than 20 kg, with contrast use as applicable to the region.
Olea Medical S.A.S.
Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter...
NeuroSpectrum Insights Corp.
Adjunctive quantitative brain-mapping report for qualified clinical interpretation of children 24-36 months, providing regional volume, surface-area and local-gyrification...
Canon Medical Systems Corporation
Canon Vantage Fortian and Orian 1.5T MR systems acquire and display diagnostic MR images of the labeled head and body, including the described noncontrast MR angiography workflow.
Shanghai United Imaging Healthcare Co., Ltd.
uMR Ultra is a diagnostic MR system for imaging the labeled head, body, and extremities.
Shanghai United Imaging Healthcare Co., Ltd.
uMR 680 is a diagnostic MR system for imaging the labeled head, body, and extremities.
SimBioSys, Inc.
TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction,...
Siemens Shenzhen Magnetic Resonance, Ltd.
MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and...
Siemens Healthcare GmbH
MAGNETOM Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile with syngo MR XA70A produce diagnostic MR images, spectra, and derived physical parameters and add model-specific Deep...
Sora Neuroscience, Inc.
Cirrus processes MR data, including resting-state BOLD fMRI, to provide task-analogous motor, language, and vision correlation maps in DICOM for external visualization or...
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...
Philips Medical Systems Nederland B.V.
The Philips 1.5T and 3T MRI system family with release R12.3 supports broad diagnostic and interventional imaging and adds SmartSpeed Precise machine-learning reconstruction.
Hyperfine, Inc.
Swoop Portable MR Imaging System V2 is a portable ultra-low-field MR system for head imaging in adult and pediatric patients, including neonates, at the point of care when a...
Shanghai United Imaging Healthcare Co., Ltd.
uMR Omega is an MR diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and physical parameters...
Hyperfine, Inc.
Swoop Portable MR Imaging System is a portable ultra-low-field MR system for head imaging in adult and pediatric patients at the point of care when conventional full diagnostic...
Galileo CDS, Inc
Post-processing automatic segmentation, quantification, and reporting of brain FLAIR hyperintensity volumes to support structural MRI review; not disease detection or diagnosis.
Foqus Technologies Inc.
DeepFoqus-Accelerate accepts and transfers brain MRI DICOM studies and reconstructs non-contrast sagittal, axial, and coronal T1, T2, and FLAIR images from supported 1.5T and 3T...
Quibim S.L.
QP-Prostate CAD detects and marks suspected prostate lesions for clinically significant prostate cancer on bi-parametric T2-weighted and diffusion-weighted prostate MRI, returning...
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...
Siemens Healthcare GmbH
Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior...
Phantomics Inc.
Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including...
ScanDiags AG
Semi-automatic lumbar MRI segmentation and area and distance measurements with radiologist-approved PDF report to PACS; adjunct only.
Subtle Medical, Inc.
MRI image enhancement through noise reduction and sharpening for clinical image review.
Prenuvo
Prenuvo Body Composition is software that non-invasively quantifies fat, muscle, and organs from compatible MR DICOM datasets and displays internal body information, including...
Canon Medical Systems Corporation
Vantage Galan 3T is a head and body diagnostic MRI system with noncontrast MRA and AiCE deep-learning reconstruction; K243335 also covers the PIQE image-processing workflow under...
Ezra AI, Inc.
Ezra Flash enhances non-contrast MRI by reducing noise on supported 1.5T and 3T Siemens or GE systems for adults, including head sagittal T1 and axial T2 or FLAIR, abdomen axial...
MSKai
Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is...
Oxford Brain Diagnostics Ltd
Assist trained healthcare practitioners in viewing, analyzing, quantifying, and evaluating MR brain images of adults older than 45 years, including segmentation, normative...
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...
icometrix NV
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection,...
TeraRecon,Inc.
Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final...
Remedy Logic Inc.
RemedyLogic AI MRI Lumbar Spine Reader (“RAI”) is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired...
Neurophet, Inc.
Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data...
SimBioSys, Inc.
Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable...
NordicNeurolab AS
Analyze and visualize functional and dynamic brain MR data and present derived properties and parameters in a clinically useful context for qualified medical personnel; it is not...
GE Medical Systems, LLC
SIGNA MAGNUS is a head-only MR system intended for diagnostic imaging of structures and functions of the head, neck, temporomandibular joint, and limited cervical spine in...
Springbok, Inc.
Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat...
Q Bio, Inc.
Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions using whole-body DICOM MR images gathered on a GE MR450W....
CorTechs Labs, Inc.
NeuroQuant automatically labels, visualizes, and volumetrically quantifies segmentable brain structures and lesions from MR images, optionally using T2 FLAIR and T2* GRE/SWI for...
Subtle Medical, Inc.
Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
Canon Medical Systems Corporation
The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a magnetic-resonance diagnostic device for producing cross-sectional MR images and related...
Smart Soft Healthcare
CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
FUJIFILM Healthcare Corporation
The ECHELON Synergy MRI System provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved cross-sectional images of...
Rebrain, SAS
OptimMRI is intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. It can process preoperative...
MRIMath LLC
Semi-automatic segmentation, labeling, and volumetric quantification of known WHO grade 4 glioblastoma in adults aged 18 years or older using T1 post-contrast or FLAIR MRI.
Microstructure Imaging, Inc.
MICSI-RMT is image-processing software for MRI image enhancement and noise reduction in head MRI images. The FDA material describes analysis of functional and diffusion MRI images...
Hyperfine, Inc.
Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI...
Subtle Medical, Inc.
SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.
JLK Inc.
Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related...
Fujifilm Healthcare Americas Corporation
ECHELON Synergy V10.0 is a magnetic-resonance diagnostic system that provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique,...
Shanghai United Imaging Healthcare Co., Ltd
uMR Jupiter is a magnetic-resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images, spectroscopic images, and physical...
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 Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR is a magnetic-resonance diagnostic device for producing cross-sectional MR images...
Shanghai United Imaging Healthcare Co., Ltd.
The uMR 680 is a magnetic-resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images, spectroscopic images, and physical...
Siemens Medical Solutions USA, Inc.
MAGNETOM Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head...
Shanghai United Imaging Healthcare Co., Ltd.
The uMR Omega is a magnetic-resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images and spectroscopic images displaying...
MRIguidance B.V
MRI-based BoneMRI image enhancement for visualizing pelvic and cervical, thoracic, lumbar and S1 spinal bone structures with CT-like radiodensity contrast; not for tumor diagnosis...
Siemens Medical Solutions USA, Inc.
MAGNETOM Cima.X Fit is a magnetic-resonance diagnostic device that produces transverse, sagittal, coronal, and oblique images, spectroscopic images and spectra, and physical...
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,...
SimBioSys, Inc.
TumorSight Viz analyzes dynamic contrast-enhanced breast MRI for visualization and analysis of biopsy-proven early-stage or locally advanced breast cancer, including registration,...
Siemens Medical Solutions USA, Inc.
MAGNETOM Sola and Altea with syngo MR XA61A provide standard head, body, extremity, and interventional MRI and add release-specific Deep Resolve, OpenRecon, implant-suite, and...
Siemens Medical Solutions USA, Inc.
MAGNETOM Cima.X produces cross-sectional and spectroscopic MR images of the head, body, and extremities for qualified professional interpretation; exact field strength, coils,...
Sydney Neuroimaging Analysis Centre Pty Ltd
Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same...
Quibim S.L.
Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and...
Circle Cardiovascular Imaging
Myocardial Strain Software Application provides qualitative and quantitative evaluation of cardiovascular MR images, including two-dimensional displacement, velocity, strain,...
Siemens Medical Solutions USA, Inc.
MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an...
Siemens Medical Solutions USA, Inc.
MAGNETOM Free.Max and Free.Star are 0.55T MRI systems for broad head, body, extremity, and release-specific diagnostic imaging workflows.
AIRS Medical Inc.
Accept, enhance, and transfer all-body MR images in DICOM format using noise reduction and image sharpening; it is not intended for mobile devices.
Siemens Medical Solutions USA, Inc.
MAGNETOM Aera, Skyra, Prisma, Prisma fit, Vida, and Lumina with syngo MR XA60A are 1.5T and 3T MRI systems that produce cross-sectional images, spectroscopic images or spectra,...
Siemens Medical Solutions U.S.A.
Post-processing image analysis to assist clinicians in viewing, analyzing, and evaluating MR brain images through automated segmentation, quantitative analysis, normative...
Heuron Co., Ltd.
Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a...
Hyperfine, Inc.
The Swoop Portable MR Imaging System is a portable, ultra-low-field, bedside magnetic-resonance device for producing images that display the internal structure of the head where a...
VUNO Inc.
Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
AI Medical AG
Jazz semi-automatically labels, visualizes, and quantifies segmentable brain structures on MR for patients with known multiple sclerosis and/or brain metastasis, with...
In-Med Prognostics L3C
NEUROShield labels, visualizes, and quantifies hippocampal volume from brain MRI as decision support for neurologists and neuroradiologists.
Siemens Medical Solutions USA, Inc.
The MAGNETOM Viato.Mobile is an MR diagnostic device that produces transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images or spectra, and other...
Canon Medical Systems Corporation
Vantage Galan 3T with MRT-3020 and V9.0 with AiCE Reconstruction Processing Unit acquires and reconstructs labeled diagnostic MR examinations on the compatible scanner...
AIRAmed GmbH
AIRAscore automatically labels, visualizes and quantifies segmentable brain structures from MR images, replacing manual volume measurement and providing reference-adjusted reports...
Imeka Solutions, Inc.
ANDI processes diffusion-weighted MRI with auxiliary T1 imaging to create 3D white-matter tract maps and microstructure reports for trained medical professionals as adjunctive...
RebrAIn, SAS
OptimMRI processes preoperative DICOM-compatible MR images to generate three-dimensional annotated brain models that aid neurosurgical functional planning and may aid localization...
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,...
Resonance Health Analysis Services Pty Ltd
Provide quantitative volumetric liver fat fraction, proton-density fat fraction, and steatosis grading to support clinical diagnosis and subsequent management decisions for...
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...
Subtle Medical Inc.
MRI image enhancement by reducing image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increasing image sharpness for head MRI.
NEUROPHET, Inc.
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with optional comparison of volumetric data to reference...
Olea Medical
MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements;...
Quantib BV
Support trained medical professionals in processing, visualizing, editing, and interpreting prostate MR studies, including structured PI-RADS scoring; diagnosis must not be made...
Ezra AI, Inc.
Ezra Flash is MR image-processing software used to reduce image noise in non-contrast MRI examinations acquired on 3-Tesla Siemens and GE scanners for sagittal T1, axial T2, and...
Philips Medical Systems Nederland B.V.
The Philips Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300, and MR 7700 systems provide head, body, and extremity MRI with SmartSpeed AI reconstruction or...
Siemens Medical Solutions USA Inc.
MAGNETOM Amira and MAGNETOM Sempra produce diagnostic MR images in the labeled scanner, coil, sequence, anatomy, and professional-interpretation workflow.
MRIguidance B.V.
MRI-based BoneMRI v1.6 image enhancement for visualizing pelvic and L3-S1 lumbar bone structures with enhanced contrast; not for tumor diagnosis or monitoring and not a CT...
Hyperfine, Inc.
The Swoop Portable MR Imaging System is a bedside magnetic-resonance device for producing images that display the internal structure of the head where a full diagnostic...
Shanghai United Imaging Intelligence Co., Ltd.
The uMR 680 is an MR diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images and spectroscopic images displaying internal anatomy or...
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,...
Olea Medical
MR Diffusion Perfusion Mismatch V1.0 is image-processing software for computing parametric maps from MR diffusion-weighted and perfusion-weighted imaging, extracting...
Philips Medical Systems Nederlands B.V.
MR 5300 and MR 7700 R11 produce cross-sectional MR images, spectra, and derived parameters of the head, body, and extremities and support labeled interventional MR-fluoroscopy...
Hyperfine, Inc.
BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and...
Hyperfine, Inc.
The Swoop Portable MR Imaging System is a bedside magnetic-resonance imaging device for producing images that display the internal structure of the head where a full diagnostic...
Avenda Health, Inc.
The Avenda Health AI Prostate Cancer Planning Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic...
MRlguidance B.V.
BoneMRI enhances bone contrast in dedicated MRI examinations of the pelvic sacrum, hip bones, femoral heads, and lumbar spine from L3 through S1; it is not intended to diagnose or...
Shanghai United Imaging Healthcare Co.,Ltd.
The uMR Omega System is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and...
CASIS Cardiac Simulation & Imaging Software
QIR Suite is intended to be used for viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM (Digital Imaging and...
Neosoma Inc.
Semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma, including WHO grade 3 astrocytoma, grade 4 astrocytoma, and grade 4 glioblastoma,...
Siemens Medical Solutions USA, Inc.
MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit with syngo MR XA51A produce cross-sectional and spectroscopic MR images and physical parameters of the head, body, and...
Perspectum
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display...
ClearPoint Neuro, Inc.
ClearPoint Maestro Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images. This...
Hyperfine, Inc.
Swoop Portable MR Imaging System is a point-of-care head MRI system for adult and pediatric patients, including settings such as emergency, critical care, hospital, and...
AI4MedImaging Medical Solutions S.A.
Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone...
Hyperfine, Inc.
BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and...
ScanMed, LLC
Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or...
Siemens Medical Solutions USA, Inc.
MAGNETOM Free.Max and MAGNETOM Free.Star produce diagnostic MR images in the labeled scanner, coil, sequence, anatomy, and professional-interpretation workflow.
Smart Soft Healthcare AD
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR)...
Hyperfine, Inc.
Swoop Portable MR Imaging System is a point-of-care head MRI system for adult and pediatric patients in emergency, critical-care, hospital, and rehabilitation settings where a...
GE Medical Systems,LLC (GE Healthcare)
AIR Recon DL is optional integrated GE MRI reconstruction that removes noise and ringing from supported 1.5T, 3T, and 7T acquisitions across all ages and anatomies.
AIRS Medical Inc.
SwiftMR is image-processing software that enhances supported MRI DICOM images by reducing noise or increasing sharpness within the labeled workflow; exact scanner, sequence,...
Philips Medical Systems Nederland B.V.
The Philips Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR systems provide head, body, and extremity MRI, with SmartSpeed AI deep-learning acceleration in...
Siemens Medical Solutions USA, Inc.
MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...
Quantib BV
Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume...
Siemens Medical Solutions USA Inc.
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A produce diagnostic MR images in the labeled scanner and protocol workflow for professional interpretation.
Siemens Healthcare GmBh
AI-Rad Companion Brain MR VA40 post-processes head MR images to segment and quantify brain structures and white-matter hyperintensities, compare normalized values with healthy...
Canon Medical Systems Corporation
Vantage Galan 3T with MRT-3020 V8.0 and the AiCE Reconstruction Processing Unit for MR produces cross-sectional and spectroscopic MR images and physical parameters of the head,...
Siemens Medical Solutions USA, Inc.
MAGNETOM Avanto Fit is a diagnostic MR system that produces transverse, sagittal, coronal, and oblique images, spectroscopic images and spectra, and physical parameters of the...
Arterys Inc.
Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store...
Siemens Medical Solutions USA, Inc.
MAGNETOM Vida with syngo MR XA50A is a diagnostic MR system that produces cross-sectional and spectroscopic images and physical parameters of the head, body, and extremities for...
GE Healthcare(Tianjin) Company Limited
SIGNA Artist Evo is a diagnostic MR system for acquisition, reconstruction, display, and professional interpretation within the labeled scanner, coil, sequence, and anatomy scope.
GE Healthcare (GE Medical Systems, LLC)
SIGNA Hero is a 3.0T whole-body MR system for acquiring, reconstructing, displaying, and exporting labeled diagnostic MR examinations with supported coils, sequences, and...
GE Healthcare (Tianjin) Company Limited
SIGNA Prime is a whole-body 1.5T MR system for acquiring, reconstructing, displaying, and exporting labeled diagnostic MR examinations with supported coils, sequences, and...
Quantib B.V.
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with complementary segmentations, visualizations, and volume...
Resonance Health Analysis Services Pty Ltd
LiverSmart is indicated to -For Liver Iron Concentration:(i) measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;(ii) monitor liver...
MRIguidance B.V
BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and...
Vysioneer Inc.
VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas...
Canon Medical Systems Corporation
Vantage Fortian 1.5T with MRT-1550 V8.0 and the AiCE Reconstruction Processing Unit for MR produces diagnostic MR images and physical parameters of the head, body, and extremities...
CorTechs Labs, Inc
OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data. OnQ Neuro is intended to provide automatic...
Hyperfine, Inc.
Swoop Point-of-Care Magnetic Resonance Imaging Scanner System provides point-of-care MR images of the head for the labeled adult and pediatric workflow, with interpretation and...
AIRS Medical Inc.
SwiftMR is image-processing software that enhances supported MRI DICOM images by reducing noise or increasing sharpness within the labeled workflow; exact scanner, sequence,...
Siemens Medical Solutions USA, Inc.
MAGNETOM Free.Max with syngo MR XA40A is a 0.55T, 80-cm-bore system for broad head, body, and extremity diagnostic MRI.
GE Medical Systems, LLC
SIGNA 7.0T is a whole-body MR scanner for diagnostic and spectroscopic images, maps, spectra, and dynamic images of structures and functions of the head and extremities in...
Siemens Medical Solutions USA, Inc.
MAGNETOM Vida, Sola, Lumina, and Altea acquire cross-sectional images, spectra, and derived physical parameters of the head, body, and extremities for trained physician...
Canon Medical Systems Corporation
Vantage Galan 3T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can also...
Subtle Medical, Inc.
SubtleMR is MRI image-processing software for reducing noise in supported head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI or increasing sharpness for...
QUIBIM S.L.
qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The...
Canon Medical Systems Corporation
Vantage Orian 1.5T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can also...
Perspectum Ltd.
Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health. Hepatica...
Hyperfine Research, Inc
BrainInsight automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images, returning annotated or segmented images, color...
Resonance Health Analysis Services Pty Ltd
HepaFat-AI assesses volumetric liver fat fraction, proton-density fat fraction, and steatosis grade in confirmed or suspected fatty-liver disease, supports monitoring of liver fat...
ADM Diagnostics, Inc.
The CorInsights MRI Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from MR...
GE Medical Systems SCS
PROView is an aiding tool for the clinicians to review multi-parametric prostate MR images following PI-RADS guidelines. It displays acquired and reformatted data for...
GE Medical Systems, LLC
SIGNA 7.0T is a whole-body magnetic-resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra, and...
Quantib BV
Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional...
Perspectum LTD
LiverMultiScan LMSv4 processes abdominal MRI, including liver images, to generate pixel maps and measurements for proton-density fat fraction, T2 star, and corrected T1, with...
CorticoMetrics LLC
Automatically label, visualize, and volumetrically quantify segmentable brain structures from MR images; volumetric measurements may be compared with reference percentile data.
GE Healthcare (Tianjin) Company Limited
SIGNA Artist is a 1.5T whole-body MRI system; K202238 adds AIR Recon DL reconstruction to reduce noise and ringing and support improved image quality or shorter acquisitions.
Siemens Medical Solutions USA Inc.
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images.
Canon Medical Systems Corporation
Vantage Orian 1.5T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can perform...
Ezra AI Inc.
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, three-dimensional visualization, and comparison of MR medical images. It supports an oncologic...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Brain MR post-processes typical head-MR T1 MPRAGE images to automatically segment and quantify brain structures, compare normalized volumes with healthy reference...
Shanghai United Imaging Healthcare Co., Ltd
uWS-MR provides MR image viewing, manipulation, communication, storage, stitching, fusion, spectroscopy, parameter maps, breast evaluation, brain perfusion, and related processing...
Shanghai United Imaging Healthcare Co., Ltd
uMR 780 MRDD produces cross-sectional, oblique, and spectroscopic MR images and physical parameters of the head, body, and extremities for interpretation by trained physicians.
GE Healthcare (GE Medical Systems, LLC)
SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option...
Canon Medical Systems Corporation
Vantage Galan 3T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can also...
Icometrix NV
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended...
Qynapse
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not...
MultiModal Imaging Services Corporation (dba HealthLytix)
RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+...
HeartVista, Inc.
Accessory acquisition, reconstruction, and display of cardiovascular MR images on compatible 1.5T and 3T whole-body MRI systems for trained-physician interpretation.
Subtle Medical, Inc.
SubtleMR is MRI image-processing software for enhancing supported MRI images within the exact submission workflow; the older submission's scanner, sequence, anatomy, and output...
Perspectum Diagnostics Ltd
LiverMultiScan LMSv3 is MR diagnostic software for non-invasive liver evaluation from abdominal MR images, including automated liver segmentation and proton-density fat fraction,...
GE Medical Systems, LLC
SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K183231 adds AIRx, a deep-learning pre-scan feature that automates and...
Perspectum Diagnostics Ltd
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation,...
Quantib BV
Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional...
AMRA Medical AB
AMRA Profiler is MR diagnostic software for non-invasive fat and muscle evaluation, including liver fat fraction, T2 star, and muscle volume measurements from supported DICOM MR...
Resonance Health Analysis Services Pty Ltd
FerriSmart analyzes magnetic resonance images to estimate liver iron concentration for clinician review.
Quantib BV
Automatic brain-structure labeling, visualization, volumetric quantification, and WMH-candidate assessment as complementary information for trained professionals evaluating MR...
Medic Vision - Imaging Solutions Ltd
iQMR is DICOM MRI networking, communication, processing, and enhancement software for trained professionals; lesions, masses, or abnormalities smaller than 1.5 mm may not be...
Combinostics Oy
cNeuro cMRI is intended for automatic labeling, quantification and visualization of segmentable brain structures from a set of MR images. the software is intended to automate the...
CorTechs Labs, Inc
NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images.
Quantitative Insights, Inc
QuantX is breast MRI software for the labeled management, analysis, visualization, and decision-support workflow; exact image inputs, outputs, and use remain submission-specific.
Surgical Information Sciences, Inc.
SIS Software fuses brain MRI with postoperative CT to visualize and localize the subthalamic nucleus for stereotactic neurosurgical planning.
Quantib BV
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...
ARTERYS INC.
Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize...
Icometrix
icobrain segments and quantifies brain structures and lesions from T1-weighted and FLAIR MRI using cross-sectional and longitudinal workflows with acquisition-consistency limits.
QUANTIB BV
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...
IMAGING BIOMETRICS, LLC
Post-processing of dynamic brain MRI to generate perfusion maps for trained-physician interpretation.