FDA 510(k) Application Details - K061255

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K061255
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant KYRON CLINICAL IMAGING, INC.
2457 N. MAYFAIR RD., SUITE 202
WAUWATOSA, WI 53226 US
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Contact JAMES L REUSS
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 05/04/2006
Decision Date 06/13/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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