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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 K071972
Device Name ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
Applicant
AGFA HEALTHCARE CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Applicant Contact TOM HOLBROOK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/17/2007
Decision Date 07/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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