ClearanceBrief
510(k) K102011 ยท MUJ System, Planning, Radiation Therapy Treatment

ECLIPSE TREATMENT PLANNING SYSTEM

ApplicantVarian Medical Systems, Inc., Palo Alto CA, US
DecisionSubstantially Equivalent, Sep 3, 2010
ReceivedJul 16, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K102011

DateFirm and productCodeLinked 510(k)
Feb 20, 2013Varian Medical Systems, Inc. Oncology Systems
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the
Terminated
MUJNone listed
Sep 26, 2012Varian Medical Systems, Inc. Oncology Systems
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Pal
Terminated
MUJNone listed
Mar 6, 2012Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS)
Terminated
MUJNone listed
Jan 13, 2012Varian Medical Systems, Inc. Oncology Systems
Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical S
Terminated
MUJNone listed
Jul 11, 2011Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy treatment for patients with malignant and benign diseases.
Terminated
MUJNone listed

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