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510(k) Data Aggregation
K Number
K092308Device Name
POLESTAR, MODEL N-30
Manufacturer
Date Cleared
2010-03-16
(229 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC NAVIGATION ISRAEL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PoleStar N-30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of be bead selected by the physician. The images produced by the PoleStar N-30 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance.
The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and T2*
Anatomical regions: sections of the head selected by the physician.
Nuclei excited: H-1
Diagnostic uses: T1, T2, T2* and density weighted imaging.
The PoleStar N-30 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
Device Description
The PoleStar N30 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The PoleStar N30 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N30 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.
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