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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 K052358
Device Name ETIAM STAR PACS COMPONENTS
Applicant
Etiam, S.A.
1600 Manchester Way
Denton,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
Etiam, S.A.
1600 Manchester Way
Denton,  TX  76210
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/29/2005
Decision Date 10/05/2005
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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