FDA 510(k) Application Details - K151438

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151438
Device Name System, Image Processing, Radiological
Applicant REALCLOUD IMAGING INC.
2060 ALAMEDA PADRE SERRA, SUITE 100
SANTA BARBARA, CA 93013 US
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Contact DOUGLAS A. GOLAY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/29/2015
Decision Date 07/07/2015
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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