FDA 510(k) Application Details - K130228

Device Classification Name System, Image Processing, Radiological

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510(K) Number K130228
Device Name System, Image Processing, Radiological
Applicant NEOSOFT, LLC
N27 W23910A PAUL RD.
PEWAUKEE, WI 53186 US
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Contact JACKIE SCHWABE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/29/2013
Decision Date 03/20/2013
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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