Modality
219 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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Canon Medical Systems Corporation
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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)
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.
Galileo CDS, Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
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.
NeuroSpectrum Insights Corp.
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.
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Oxford Brain Diagnostics Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Mycardium AI Limited
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
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection 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....
Remedy Logic Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Neurophet, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
SimBioSys, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
NordicNeurolab AS
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems, 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.
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.
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Subtle Medical, 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.
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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
BoneMRI is image-processing software that enhances visualization of pelvic and spinal bone structures in MRI images relative to surrounding soft tissue.
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Quibim S.L.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
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.
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Heuron Co., Ltd.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
AI Medical AG
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.
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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
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.
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.
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.
NEUROPHET, 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.
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
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.
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.
BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
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...
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.
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.
CASIS Cardiac Simulation & Imaging Software
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Neosoma Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
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
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.
ClearPoint Neuro, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
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.
Hyperfine, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
ScanMed, LLC
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
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.
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.
Resonance Health Analysis Services Pty Ltd
FDA product code PCS identifies this device class as Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox. Intended for diagnostic use to present images that...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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,...
Olea Medical
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
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.
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.
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.
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.
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.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems SCS
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems, 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
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE 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.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Canon Medical Systems Corporation
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
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.
Qynapse
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.
MultiModal Imaging Services Corporation (dba HealthLytix)
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.
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.
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
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.
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
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.
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...
Medicrea International
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.
Combinostics Oy
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.
CorTechs Labs, Inc
is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...
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.
MEDICREA INTERNATIONAL
UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries.
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
Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).
ARTERYS INC.
The device is intended to visualize and quantify MRI data in DICOM format.
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
Quantib Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS
IMAGING BIOMETRICS, LLC
Post-processing of dynamic brain MRI to generate perfusion maps for trained-physician interpretation.