510(k) K092871 ยท IYE Accelerator, Linear, Medical
TRILOGY MX
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Nov 30, 2009 |
| Received | Sep 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Varian Medical Systems, Inc. Oncology Systems On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0;
Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
The On-Board Imager Terminated |
IYE | None listed |
| Jul 8, 2011 | Varian Medical Systems, Inc. Oncology Systems TrueBeam Linear Accelerators (aka Trilogy Mx)
Varian Medical Systems, Palo Alto, CA
Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and c Terminated |
IYE | None listed |
| May 10, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19; Terminated |
IYE | None listed |
| Jan 31, 2011 | Varian Medical Systems Oncology Systems Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
The system cons Terminated |
IYE | None listed |
| Oct 20, 2010 | Varian Medical Systems Oncology Systems Varian brand TrueBeam and TrueBeam STx,
Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.