FDA 510(k) Application Details - K051639

Device Classification Name System, Image Processing, Radiological

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510(K) Number K051639
Device Name System, Image Processing, Radiological
Applicant AS SOFTWARE, INC.
80 SOUTH WOODLAND STREET
ENGLEWOOD, NJ 07631 US
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Contact KIM A NATHANSON
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/20/2005
Decision Date 08/02/2005
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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