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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 K040376
Device Name SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE
Applicant
Sectra-Imtec AB
1600 Manchester Way
Denton,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
Sectra-Imtec AB
1600 Manchester Way
Denton,  TX  76210
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/17/2004
Decision Date 05/04/2004
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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