FDA 510(k) Application Details - K151687

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151687
Device Name System, Image Processing, Radiological
Applicant 3DISC AMERICAS
22560 GLENN DR STE 116
STERLING, VA 20164 US
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Contact SIGRID SMITT-JEPPESEN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/23/2015
Decision Date 08/03/2015
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 N
Expedited Review



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