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510(k) Data Aggregation
K Number
K141472Device Name
VANTAGE ELAN
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS INC
Date Cleared
2014-09-19
(108 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
TOSHIBA AMERICA MEDICAL SYSTEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- · Proton density (PD) (also called hydrogen density)
- · Spin-lattice relaxation time (T1)
- · Spin-spin relaxation time (T2)
- Flow dynamics
- · Chemical Shift
Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Device Description
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
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