FDA 510(k) Application Details - K131873

Device Classification Name System, Image Processing, Radiological

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510(K) Number K131873
Device Name System, Image Processing, Radiological
Applicant METHODSENSE, INC.
P.O. BOX 110352
DURHAM, NC 27709 US
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Contact RITA KING
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/24/2013
Decision Date 09/25/2013
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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