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FDA 510(k) Application Details - K163232
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K163232
Device Name
System, Image Processing, Radiological
Applicant
Vital Images, Inc
5850 Opus Parkway
Suite 300
Minnetonka, MN 55343 US
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Contact
Fei Li
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
11/17/2016
Decision Date
07/21/2017
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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