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510(k) Data Aggregation
K Number
K162863Device Name
dS Small Extremity 16CH 1.5T Coil
Manufacturer
INVIVO THERAPEUTICS CORPORATION
Date Cleared
2016-11-07
(25 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
INVIVO THERAPEUTICS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dS Small Extremity 16Ch 1.5T Coil is to be used in conjunction with a Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the extremities that can be interpreted by a trained physician.
Device Description
The proposed dS Small Extremity 16Ch 1.5T Coil is designed for use with Magnetic Resonance Imaging (MRI) systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The proposed dS Small Extremity 16Ch 1.5T Coil is a volume phased array receive-only coil for high resolution diagnostic imaging of small extremities. The coil is made of two flexible flaps and adjustable straps for ease of workflow. The coil rigid housing is made with Lexan 925 material and the foamed pad is coated with Dartex Polyurethane; with dimensions to be 13.5"x10x9 inches to accommodate 16 Channel construction; the former using Kapton rigid-Flex PCB (loop elements) and FR-4 PCB (feedboard, interface boards), and urethane-jacketed cable to connect to MR system. The coil provides unilateral images (Left and Right) of the anatomy of interest.
The small extremity (Hand, Finger, Elbow) comfort pads are made of Urethane core with Polyvinyl Nitrile wrap, coated with Polyscan material; the Base Plate and Table Pads are also coated with Polyscan material.
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