GREY:IMRSQ - Post by User
Post by
erasmus2010on Jan 17, 2013 11:02am
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Post# 20850853
VISIUS Wireless Coil 510(k) FDA Approval
VISIUS Wireless Coil 510(k) FDA Approval Link to FDA approval document December 27, 2012.
Will produce some recuring revenue and simplify operatering room procedures.
This is the first FDA approval for a wireless coil and is for both 1.5T and 3.0T Imris/Siemens MRI systems. It is substantially equivalent to previously approved Imris head coils.
https://www.accessdata.fda.gov/cdrh_docs/pdf12/K123091.pdf