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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 K150707
Device Name IntelePACS
Applicant
Intelerad Medical Systems Incorporated
895 De La Gauchetiere St.
West, Suite 400
Montreal,  CA H3B 4G1
Applicant Contact Ms. Luce Caron
Correspondent
O Tech, Inc.
8317 Belew Dr.
Mckinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/19/2015
Decision Date 05/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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