FDA 510(k) Application Details - K071492

Device Classification Name System, Image Processing, Radiological

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510(K) Number K071492
Device Name System, Image Processing, Radiological
Applicant RIVERAIN MEDICAL GROUP,LLC
3020 SOUTH TECH BLVD.
MIAMISBURG, OH 45342-4860 US
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Contact JENNIFER STEINKE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/30/2007
Decision Date 08/28/2007
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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