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510(k) Data Aggregation
K Number
K092899Device Name
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
Manufacturer
NINGBO XINGAOYI MAGNETISM CO., LTD.
Date Cleared
2009-11-10
(50 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
NINGBO XINGAOYI MAGNETISM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OPER Series Open Type Permanent-Magnet MRI System is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the OPER Series Open Type Permanent-Magnet MRI 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 (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
The OPER Series Open Type Permanent-Magnet MRI System (OPER MRI) is a series of open permanent magnet MRI system, with magnetic field strength of 0.3T, and 0.4T, respectively. The model number for each of the corresponding system is OPER-0.3, OPER-0.35, and OPER-0.4, respectively. The OPER MRI system utilizes a permanent magnet to acquire 2D single-slice and multislice and 3D volume images. A wide range of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery and flow compensation are provided to suppress artifacts due to physiological motion and improve image quality.
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