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510(k) Data Aggregation
K Number
K110487Device Name
FLEXIBLE CARDIAC COIL
Manufacturer
Date Cleared
2011-04-19
(56 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
LBDS HOLDING COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1.5T MRI systems are intended for use as NMR devices that produce images that (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Flexible Cardiac Coil is indicated for use with Philips 1.5T MRJ systems in the following anatomic regions and with the designated nuclei. Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen
Device Description
Flexible Cardiac Coil
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