510(k) K904364 ยท IYE Accelerator, Linear, Medical
VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C
| Applicant | Varian Assoc., Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Feb 27, 1991 |
| Received | Sep 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2011 | Varian Medical Systems Oncology Systems Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX Terminated |
IYE | None listed |
| Feb 1, 2011 | Varian Medical Systems Oncology Systems Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers:
H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA Terminated |
IYE | None listed |
| Jan 8, 2011 | Varian Medical Systems Oncology Systems Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alt Terminated |
GKZ | None listed |
| Aug 27, 2009 | Varian Medical Systems Oncology Systems Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA.
Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray Terminated |
IYE | None listed |
| Oct 20, 2008 | Varian Medical Systems Oncology Systems Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assemb Terminated |
IYE | None listed |
| Sep 9, 2005 | Varian Medical Systems Inc Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac);
Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304. Terminated |
IYE | None listed |
| Apr 27, 2005 | Varian Medical Systems Inc Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.