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FDA 510(k) Application Details - K083084
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K083084
Device Name
System, Image Processing, Radiological
Applicant
ZIOSOFT, INC.
2200 BRIDGE PARKWAY, SUITE 103
REDWOOD CITY, CA 94065 US
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Contact
RICHARD BALL
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
10/16/2008
Decision Date
12/19/2008
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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