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510(k) Data Aggregation
K Number
K083691Device Name
BONEVUE
Manufacturer
Date Cleared
2009-02-25
(75 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MICROMRI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BoneVue is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. BoneVue is a workflow tool intended to assist a trained physician in the assessment of high-resolution MRI datasets of bone.
Device Description
BoneVye evaluates high-resolution MRI datasets containing bone tissue and provides 3D visualization of trabecular structures as well as measurements of descriptive parameters regarding cortical and trabecular morphology.
The following cortical measurements are reported: average cortical inner diameter, average cortical outer diameter, and average cortical thickness.
The following trabecular measurements are reported: average measures of bone volume/total volume, trabecular thickness, trabecular number, and trabecular separation.
The 3D visualization module is used to display a high resolution 3D model of the trabecular bone and its micro-architecture. The 3D visualization helps a trained physician make a qualitative assessment of bone micro-architecture, which may be viewed from different angles. BoneVue allows standard surface rendering views as well as standard maximum intensity projection views.
Additionally, BoneVue offers the display of a standard "bone plug", a surface rendering of a central cylinder of trabecular tissue, as a representative sample of the bone microarchitecture.
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K Number
K073131Device Name
MICROMRI WRIST COIL
Manufacturer
Date Cleared
2008-01-18
(73 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MICROMRI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MicroMRI Wrist Coll is a transmitting and receiving device to be used in conjunction with GE Healthcare and Siemens 1.5T MRI systems to image the wrist. The images acquired using the MicroMRI Wrist Coil along multiple axes (axial, coronal, sagittal, and oblique) are a measure of the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the spatial image are proton density, spin-lattice (TI) and spin-spin (T2) relaxation times, flow velocity and chemical shift. These wrist MRU images when interpreted by a trained physician can be useful in determining a diagnosis. The MicroMRI Wrist Coil cannot be used with an MRI system that supports the use of only receive coils.
Device Description
The MicroMRI Wrist Coil uses an elliptical birdcage design to provide the highest possible signal-to-noise ratio (SNR) for imaging a human wrist. The two piece structure facilitates the use of the coil for a wide range of wrist sizes. The elliptical design and ability to conform to the subject's wrist makes the coil unique and efficient in transmitting and receiving the RF signal to the anatomy (i.e., the wrist).
The accompanying immobilization system provides a means to stabilize the patient's arm during the scan. The immobilization system provides a means for positioning the patient's arm consistently in the same position and orientation.
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