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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K141881
Device Name RAPIDRESULTS
Applicant
RAMSOFT, INC.
243 COLLEGE ST.,SUITE 100
toronto, on,  CA m5t 1r5
Applicant Contact lely lam-hong
Correspondent
RAMSOFT, INC.
243 COLLEGE ST.,SUITE 100
toronto, on,  CA m5t 1r5
Correspondent Contact lely lam-hong
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/11/2014
Decision Date 10/31/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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