Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.
MYOCARDIAL SOLUTIONS, INC.
6.0.1
In Commercial Distribution

  • B672MYOSTRAIN0600010 ()


  • Radiology DICOM image processing application software
MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements
MYOCARDIAL SOLUTIONS, INC.
5.1.2
Not in Commercial Distribution

  • B672MYOSTRAIN050102 ()


  • Radiology DICOM image processing application software
The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
First Source, Inc.
V5
In Commercial Distribution

  • G221200CA3080 ()
200-CA-308

  • Radiology DICOM image processing application software
The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to aid radiologists in reading mammograms. It is a proprietary software application designed to process digitized film mammograms and digital mammograms. The mammogram images are automatically analyzed to mark areas for review by a radiologist. Results are displayed on either a mammography workstation, high resolution monitor, or printed case report.
VUCOMP, INC.
1050
In Commercial Distribution

  • M994MVU10500 ()


  • Radiology DICOM image processing application software
No Description
MEDIVIS, INC
1.1.0.0
In Commercial Distribution

  • SURGICALAR0 ()


  • Radiology DICOM image processing application software
TeraRecon Neuro allows motion correction and processes, calculates and outputs brain perfusion analysis results for functional, dynamic, and derived imaging datasets acquired with CT or MRI. TeraRecon Neuro results are used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume.
Terarecon Inc.
Neuro02
In Commercial Distribution

  • NEURO02 ()
Neuro

  • Radiology DICOM image processing application software
The LungQ software produces reproducible CT values for pulmonary tissue, providing quantitative support for diagnosis, selection of patients for treatment, treatment planning, and follow-up examinations. LungQ can be used to support the physician in the diagnosis, evaluation and documentation of pulmonary tissue images (e.g. abnormalities) from CT thoracic datasets. Analysis provided includes segmentation and isolation of sub-compartments, volumetric analysis, tissue destruction, density evaluations, airway and vessel evaluation, fissure evaluation and reporting tools.
Thirona B.V.
v3.y.z
In Commercial Distribution

  • 08719326703817 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
1.0
In Commercial Distribution

  • 08719689791056 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791049 ()


  • Radiology DICOM image processing application software
No Description.
Quantib B.V.
2.8
In Commercial Distribution

  • 08719689791308 ()


  • Radiology DICOM image processing application software
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