ClearanceBrief
510(k) K102915 ยท MUJ System, Planning, Radiation Therapy Treatment

VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM

ApplicantViewray, Incorporated, Oakwood Village OH, US
DecisionSubstantially Equivalent, Jan 12, 2011
ReceivedOct 1, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K102915

DateFirm and productCodeLinked 510(k)
May 4, 2021Viewray, Inc.
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurge
Terminated
MUJNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.