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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 K001140
Device Name IDS5 IMAGE DISPLAY SYSTEM
Applicant
Sectra AB
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Applicant Contact HERMAN OOSTERWIJK
Correspondent
Sectra AB
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Correspondent Contact HERMAN OOSTERWIJK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/10/2000
Decision Date 05/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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