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FDA 510(k) Application Details - K151435
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K151435
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
PHILIPS MEDICAL SYSTEMS MR FINLAND
AYRITIE 4
VANTAA 01510 FI
Other 510(k) Applications for this Company
Contact
JANNE MARVOLA
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/2015
Decision Date
02/25/2016
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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