ClearanceBrief
510(k) K071938 ยท MUJ System, Planning, Radiation Therapy Treatment

MONACO RTP SYSTEM

ApplicantComputerized Medical Systems, Inc., St. Louis MO, US
DecisionSubstantially Equivalent, Oct 1, 2007
ReceivedJul 13, 2007
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K071938

DateFirm and productCodeLinked 510(k)
Jun 20, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) h
Terminated
MUJNone listed
Jun 15, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (
Terminated
MUJNone listed
Jun 14, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity mo
Terminated
MUJNone listed
Jun 14, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMR
Terminated
MUJNone listed
Jun 14, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has
Terminated
MUJNone listed

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