510(k) K102011 ยท MUJ System, Planning, Radiation Therapy Treatment
ECLIPSE TREATMENT PLANNING SYSTEM
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Sep 3, 2010 |
| Received | Jul 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102011
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2013 | Varian 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 |
MUJ | None listed |
| Sep 26, 2012 | Varian 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 |
MUJ | None listed |
| Mar 6, 2012 | Varian 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 |
MUJ | None listed |
| Jan 13, 2012 | Varian 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 |
MUJ | None listed |
| Jul 11, 2011 | Varian 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 |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.