FDA 510(k) Application Details - K031473

Device Classification Name System, Image Processing, Radiological

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510(K) Number K031473
Device Name System, Image Processing, Radiological
Applicant INTUITIVE IMAGING INFORMATICS, LLC
30 HACKAMORE LN., SUITE 4
BELL CANYON, CA 91307 US
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Contact DONALD MUNDT
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/09/2003
Decision Date 10/30/2003
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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