Use case
A buyer-oriented shortlist for mri workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
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.
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.
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.
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...
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...
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....
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...
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...
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.
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.
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...
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.
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...
Subtle Medical, Inc.
MRI image enhancement through noise reduction and sharpening for clinical image review.
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....
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.
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.
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...
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...
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...
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...
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...
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....
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,...
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...
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.
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...
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...
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.
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.
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.
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...
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.
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...
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...
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.
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 Lumina and MAGNETOM Vida Fit with syngo MR XA50A produce diagnostic MR images in the labeled scanner and protocol workflow for professional interpretation.
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.
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...
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...
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...
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...
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.
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...
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...
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.
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...
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.
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...