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FDA 510(k) Application Details - K151946
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K151946
Device Name
Accelerator, Linear, Medical
Applicant
ORFIT INDUSTRIES
VOSVELD 9A, B-2110 WIJNEGEM
WIJNEGEM, BELGIUM BE
Other 510(k) Applications for this Company
Contact
EDDY MAROVOET
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/2015
Decision Date
11/09/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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