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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 K041581
Device Name COMPACS, VERSION 1.0
Applicant
Intelligent Images Srl
Viale Cembrano 4c/4
Genova (Ge),  IT I-16148
Applicant Contact MAURIZIO PAIGGIO
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 Received06/14/2004
Decision Date 06/22/2004
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
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