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510(k) Data Aggregation
K Number
K121075Device Name
NERVEVISION SOFTWARE SYSTEMS
Manufacturer
Date Cleared
2012-07-26
(108 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
3D IMAGING PARTNERS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NERVEVISION SOFTWARE SYSTEMS is a stand-alone software application to assist clinicians in segmenting and visualizing nerve anatomy from magnetic resonance images.
Device Description
The NERVEVISION SOFTWARE SYSTEMS is a software application that has been designed and developed to assist clinicians (radiologists, neurologists, medical physicists, and surgeons) in viewing magnetic resonance images. The software is capable of showing the tissue in individual images from standard Magnetic Resonance (MR) studies for axial, sagittal, or coronal views. The segmented analyses and 3D views of the anatomy can also be viewed.
The NERVEVISION SOFTWARE SYSTEMS provides clinicians with tools to efficiently contour or delineate nerve anatomy in volume data. The results can be saved in digital imaging and communications in medicine (DICOM) and bitmap image file (BMP) formats. The clinician has the ability to save the masked, marked images directly or import them to other software. NERVEVISION SOFTWARE SYSTEMS offers features including:
- . Import and export of DICOM images,
- . Saving outlines and contours in DICOM or BMP format,
- . Semi-automated segmentation,
- . Volume segmentation, visualization, and measurement,
- Edge enhancement (contour enhancement by user controlled edge snapping), .
- Standard functionalities for image visualization (adjusting contrast & brightness, . zoom, and panning)
- . Advanced functions of contour editing for manual segmentation (drawing, outlining, inflating, deflating, shifting, cutting and adding to images), and
- . User access to modify the segmentation results at any time.
The clinician retains the ultimate responsibility for making the diagnosis and patient management decisions based on the standard practices, and comparisons to individual images. The NERVEVISION SOFTWARE SYSTEMS is a set of software tools to complement manual (individual image) nerve viewing techniques.
The NERVEVISION SOFTWARE SYSTEMS does not create original input images of nerves, nor does it change the final results obtained once approved and saved by the clinical expert. As such, this software is considered to have a moderate level of concern.
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