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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 K050751
Device Name IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
Applicant
AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Applicant Contact PHIL CUSCUNA
Correspondent
AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Correspondent Contact PHIL CUSCUNA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/23/2005
Decision Date 04/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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