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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 K081469
Device Name SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
Applicant
Sectra Imtec AB
1600 Manchester Way
Denton,  TX  76210
Applicant Contact CARL ALLETO
Correspondent
Sectra Imtec AB
1600 Manchester Way
Denton,  TX  76210
Correspondent Contact CARL ALLETO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/27/2008
Decision Date 06/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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