FDA 510(k) Application Details - K080290

Device Classification Name System, Image Processing, Radiological

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510(K) Number K080290
Device Name System, Image Processing, Radiological
Applicant AMERICAN RADIOLOGIST NETWORK, INC.
1705 S. CAPITAL OF TEXAS HWY.
SUITE 500
AUSTIN, TX 78746 US
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Contact IAN GORDON
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 02/04/2008
Decision Date 02/22/2008
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 Y
Expedited Review



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