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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 K022292
Device Name IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
Applicant
AGFA CORP.
PO BOX 1927
BREVARD,  NC  28712
Applicant Contact DAVID LEDWIG
Correspondent
AGFA CORP.
PO BOX 1927
BREVARD,  NC  28712
Correspondent Contact DAVID LEDWIG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/15/2002
Decision Date 09/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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