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FDA 510(k) Application Details - K112723
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K112723
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
DOSISOFT SA
1244 FAIRWAY VALLEY COURT
LINCOLN, CA 95648 US
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Contact
ROBERT J MORTON
Other 510(k) Applications for this Contact
Regulation Number
892.5050
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Classification Product Code
MUJ
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More FDA Info for this Product Code
Date Received
09/19/2011
Decision Date
02/08/2012
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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