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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 K071297
Device Name IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
Applicant
AGFA HEALTHCARE CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Applicant Contact TOM HOLBROOK
Correspondent
AGFA HEALTHCARE CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Correspondent Contact TOM HOLBROOK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/09/2007
Decision Date 06/22/2007
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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