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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 K070080
Device Name INTELEPACS
Applicant
Intelerad Medical Systems, Inc.
460 Ste-Catherine W.
Suite 210
Montreal Quebec,  CA M3B 1A7
Applicant Contact ANIBAL JODORCOVSKY
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/09/2007
Decision Date 01/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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