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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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Disposable snap that snaps onto a Jamshidi for instrument tracking.
TrackX Technology, LLC
HANG-TEN SNAP
Not in Commercial Distribution

  • 00860099000899 ()
  • 00860099000882 ()
TX-3-3070

  • Diagnostic x-ray digital imaging system workstation application software
TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for instrument tracking. Instrument Tracker .125 IN (previously known as Snap 2 or 12)
TrackX Technology, LLC
T SNAP
Not in Commercial Distribution

  • 00860099000813 ()
  • 00860099000875 ()
TX-3-3038

  • Diagnostic x-ray digital imaging system workstation application software
Optical Tracker Snap 11 0.090 IN (previously known as Snap 1)
TrackX Technology, LLC
Snap 11
Not in Commercial Distribution

  • 00860099000806 ()
TX-3-3036

  • Diagnostic x-ray digital imaging system workstation application software
Vascular Flow Analysis System
VASSOL, INC.
VS5060
In Commercial Distribution

  • 00867170000106 ()


  • MRI system application software
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution. STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution

  • 00866463000465 ()
REF 200008

  • MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.6
Not in Commercial Distribution

  • 00864747000279 ()


  • MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.4
Not in Commercial Distribution

  • 00864747000262 ()


  • MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.3
Not in Commercial Distribution

  • 00864747000255 ()


  • MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.2
Not in Commercial Distribution

  • 00864747000248 ()


  • MRI system application software
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