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FDA 510(k) Application Details - K070205
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K070205
Device Name
System, Image Processing, Radiological
Applicant
ZIOSOFT, INC.
5405 ALTON PARKWAY
SUITE A530
IRVINE, CA 92604 US
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Contact
MARC GOODMAN
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
01/22/2007
Decision Date
03/23/2007
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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