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FDA 510(k) Application Details - K111566
Device Classification Name
Camera, Multi Format, Radiological
More FDA Info for this Device
510(K) Number
K111566
Device Name
Camera, Multi Format, Radiological
Applicant
CARESTREAM HEALTH,INC.
150 VERONA STREET
ROCHESTER, NY 14608 US
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Contact
CHRISTINE EHAMNN
Other 510(k) Applications for this Contact
Regulation Number
892.2040
More FDA Info for this Regulation Number
Classification Product Code
LMC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/06/2011
Decision Date
10/06/2011
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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