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FDA 510(k) Application Details - K060378
Device Classification Name
System, Image Processing, Radiological
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510(K) Number
K060378
Device Name
System, Image Processing, Radiological
Applicant
VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA, MN 55343 US
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Contact
TIMOTHY J KAPPERS
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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
02/14/2006
Decision Date
03/09/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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