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FDA 510(k) Application Details - K171837
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K171837
Device Name
Accelerator, Linear, Medical
Applicant
Accuray Incorporated
1240 Deming Way
Madison, WI 53717 US
Other 510(k) Applications for this Company
Contact
Keith Picker
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
06/20/2017
Decision Date
07/25/2017
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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