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FDA 510(k) Application Details - K122137
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K122137
Device Name
Accelerator, Linear, Medical
Applicant
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE, CA 94089 US
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Contact
ANNE SCHLAGENHAFT
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
07/18/2012
Decision Date
10/26/2012
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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