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FDA 510(k) Application Details - K091145
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K091145
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
ISODOSE CONTROL B.V.
MAXWELLSTRAAT 16
EDE 6716 BX NL
Other 510(k) Applications for this Company
Contact
HUB VAN DE BERGH
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
04/20/2009
Decision Date
05/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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