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FDA 510(k) Application Details - K212958
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K212958
Device Name
Accelerator, Linear, Medical
Applicant
ViewRay, Incorporated
815 E. Middlefield Road
Mountain View, CA 94043 US
Other 510(k) Applications for this Company
Contact
Sean Delaney
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
09/16/2021
Decision Date
12/14/2021
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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