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510(k) Data Aggregation
K Number
K091669Device Name
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
Manufacturer
Date Cleared
2009-06-18
(9 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
XIOAO MDT TECHNOLOGY CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Open Magnetic Resonance Imaging System, MPF3000-III is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal and oblique images that display the internal structure of the head, body or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (E) and flow.
Device Description
Open Magnetic Resonance Imaging System, MPF3000-III is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Ciient PC, and Imaging Cabinet. The system software, PROSPECT, based on Windows XP® Professional is aninteractive program with user friendly interface.
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