510(k) K111106 ยท IYE Accelerator, Linear, Medical
TRUEBEAM
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Aug 18, 2011 |
| Received | Apr 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2012 | Varian Medical Systems, Inc. Oncology Systems TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radi Terminated |
IYE | None listed |
| May 8, 2012 | Varian Medical Systems, Inc. Oncology Systems True Beam;
Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below.
Varian Medical Systems,
Palo Alto, CA.
Product Usage:
TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosu Terminated |
IYE | None listed |
| Mar 6, 2012 | Varian Medical Systems, Inc. Oncology Systems TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurg Terminated |
IYE | None listed |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator
Varian Medical Systems, Palo Alto, CA.
The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the pur Terminated |
IYE | None listed |
| Dec 2, 2011 | Varian Medical Systems, Inc. Oncology Systems TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in Terminated |
-IY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.