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FDA 510(k) Application Details - K091032
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K091032
Device Name
System, Image Processing, Radiological
Applicant
CERNER CORP.
2800 ROCKCREEK PKWY.
KANSAS CITY, MO 64117 US
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Contact
SHELLEY S LOOBY
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
04/10/2009
Decision Date
06/22/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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