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FDA 510(k) Application Details - K072821
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K072821
Device Name
System, Image Processing, Radiological
Applicant
VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA, MN 55343-4414 US
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Contact
TIMOTHY J KAPPERS
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
10/02/2007
Decision Date
02/20/2008
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
Y
Expedited Review
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