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510(k) Data Aggregation
K Number
K131737Device Name
SUPERNOVA C5 MRI SYSTEM
Manufacturer
Date Cleared
2014-10-23
(497 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
LIAONING KAMPO MEDICAL SYSTEM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Supernova C5 is intended for use as a diagnostic imaging device which can produce transverse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities. The images produced by 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
The Supernova C5 is a 0.35T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, RF Coils , Patient Couch, System Cabinet, computer system. The system software based on Windows XP or Windows 7 is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
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