FDA 510(k) Application Details - K062878

Device Classification Name System, Image Processing, Radiological

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510(K) Number K062878
Device Name System, Image Processing, Radiological
Applicant ADVANCED IMAGING SOLUTIONS, LLC
43737 N. 15TH ST. WEST
LANCASTER, CA 93534 US
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Contact RAY HASHEMI
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/26/2006
Decision Date 06/27/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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