510(k) K913119 ยท IYE Accelerator, Linear, Medical
VARIAN C-SERIES CLINACS (CLINAC 2300C/D)
| Applicant | Varian Assoc., Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Nov 7, 1991 |
| Received | Jul 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913119
| 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 |
| Jan 18, 2011 | Varian Medical Systems Oncology Systems C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA.
Device is a radiation Therapy accelerat 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 |
| Jul 12, 2007 | Varian Medical Systems Inc Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D Terminated |
IYE | None listed |
| Nov 16, 2006 | Varian Medical Systems Inc Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX) 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.