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FDA 510(k) Application Details - K000478
Device Classification Name
System, Radiation Therapy, Radionuclide
More FDA Info for this Device
510(K) Number
K000478
Device Name
System, Radiation Therapy, Radionuclide
Applicant
ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE, CA 94085 US
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Contact
LUANNE NG
Other 510(k) Applications for this Contact
Regulation Number
892.5750
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Classification Product Code
IWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/2000
Decision Date
04/19/2000
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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