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510(k) Data Aggregation
K Number
K192650Device Name
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
Date Cleared
2021-01-29
(493 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MRI Division, Beijing Wandong Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
i Space 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the 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 diagnosis determination.
Device Description
i Space 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Space 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the HHF1 by taking advantage of the imaging properties of the 1.5T magnet.
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