FDA 510(k) Application Details - K061920

Device Classification Name System, Image Processing, Radiological

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510(K) Number K061920
Device Name System, Image Processing, Radiological
Applicant NOVARAD CORP.
758 EAST UTAH VALLEY DR.
SUITE 200
AMERICAN FORK, UT 84003 US
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Contact PAUL SHUMWAY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/06/2006
Decision Date 08/21/2006
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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