FDA 510(k) Application Details - K151837

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151837
Device Name System, Image Processing, Radiological
Applicant TROPHY
4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG 77435 FR
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Contact MARIE-PIERRE LABAT-CAMY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/06/2015
Decision Date 08/19/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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