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FDA 510(k) Application Details - K071297
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K071297
Device Name
System, Image Processing, Radiological
Applicant
AGFA HEALTHCARE CORP.
10 SOUTH ACADEMY ST.
GREENVILLE, SC 29601 US
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Contact
TOM HOLBROOK
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2007
Decision Date
06/22/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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