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FDA 510(k) Application Details - K153073
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K153073
Device Name
System, Image Processing, Radiological
Applicant
INVIVO CORPORATION
3545 SW 47TH AVE.
GAINESVILLE, FL 32608 US
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Contact
Kenneth Revennaugh
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
10/22/2015
Decision Date
11/16/2015
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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