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FDA 510(k) Application Details - K063846
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K063846
Device Name
System, Image Processing, Radiological
Applicant
EIGEN
13721 VIA TRES VISTA
SAN DIEGO, CA 92129 US
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Contact
NATALIE J KENNEL
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
12/27/2006
Decision Date
01/26/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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