FDA 510(k) Application Details - K151957

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151957
Device Name System, Image Processing, Radiological
Applicant BOX INC.
4440 EL CAMINO REAL
LOS ALTOS, CA 94022 US
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Contact CRISPEN MAUNG
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/16/2015
Decision Date 09/01/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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