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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K882096
Device Name SCOPIX VIDEO IMAGER
Applicant
Agfa-Gevaert, Inc.
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Applicant Contact WILLIAM J REDDY
Correspondent
Agfa-Gevaert, Inc.
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Correspondent Contact WILLIAM J REDDY
Regulation Number892.2040
Classification Product Code
LMC  
Date Received05/18/1988
Decision Date 08/09/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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