510(k) K071873 ยท MUJ System, Planning, Radiation Therapy Treatment
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Aug 9, 2007 |
| Received | Jul 6, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2011 | Varian Medical Systems, Palo Alto, CA Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System Terminated |
MUJ | None listed |
| Nov 24, 2010 | Varian Medical Systems Oncology Systems Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x;
Model Num Terminated |
MUJ | None listed |
| Sep 22, 2009 | Varian Medical Systems Oncology Systems Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Terminated |
MUJ | None listed |
| Jan 15, 2009 | Varian Medical Systems Oncology Systems Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA.
Indicated for planning proton tr Terminated |
MUJ | None listed |
| Sep 23, 2008 | Varian Medical Systems Oncology Systems Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48 Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.