FDA 510(k) Application Details - K141881

Device Classification Name System, Image Processing, Radiological

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510(K) Number K141881
Device Name System, Image Processing, Radiological
Applicant RAMSOFT, INC.
243 COLLEGE ST.,SUITE 100
TORONTO, ON M5T 1R5 CA
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Contact LELY LAM-HONG
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/11/2014
Decision Date 10/31/2014
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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