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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 K040344
Device Name IMPAX OT3000 ORTHOPEDIC WORKSTATION
Applicant
Agfa Corp.
455 Philip St.
Waterloo, Ontario,  CA N2L 3X2
Applicant Contact PHIL CUSCUNA
Correspondent
Agfa Corp.
455 Philip St.
Waterloo, Ontario,  CA N2L 3X2
Correspondent Contact PHIL CUSCUNA
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
HWT  
Date Received02/12/2004
Decision Date 05/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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