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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 K123186
Device Name RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
Applicant
CALGARY SCIENTIFIC, INC.
SUITE 208, 1210 20TH AVENUE SE
CALGARY, ALBERTA,  CA T2G 1M8
Applicant Contact KYLE PETERSON
Correspondent
CALGARY SCIENTIFIC, INC.
SUITE 208, 1210 20TH AVENUE SE
CALGARY, ALBERTA,  CA T2G 1M8
Correspondent Contact KYLE PETERSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/11/2012
Decision Date 03/14/2013
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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