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FDA 510(k) Application Details - K152822
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K152822
Device Name
System, Image Processing, Radiological
Applicant
VIDISTAR, LLC
PO BOX 8539
GREENVILLE, SC 29604 US
Other 510(k) Applications for this Company
Contact
CRAIG WALKER
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
09/28/2015
Decision Date
11/25/2015
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
N
Expedited Review
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