ClearanceBrief
510(k) K102216 ยท MUJ System, Planning, Radiation Therapy Treatment

XIO RTP SYSTEM

ApplicantComputerized Medical Systems, Inc., Maryland Heights MO, US
DecisionSubstantially Equivalent, Oct 1, 2010
ReceivedAug 6, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K102216

DateFirm and productCodeLinked 510(k)
Aug 31, 2015Elekta, Inc.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Terminated
MUJNone listed
Mar 13, 2014Elekta, Inc.
XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and
Terminated
MUJNone listed
Feb 4, 2014Elekta, Inc.
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Terminated
MUJNone listed
Jan 17, 2014Elekta, Inc.
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and
Terminated
MUJNone listed
May 22, 2012Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Terminated
MUJNone listed
Aug 3, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external
Terminated
MUJNone listed
Jun 17, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescrib
Terminated
MUJNone listed

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