510(k) K081036 ยท IYE Accelerator, Linear, Medical
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, May 9, 2008 |
| Received | Apr 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Terminated |
IYE | None listed |
| Aug 30, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treat Terminated |
IYE | None listed |
| Jan 21, 2011 | Varian Medical Systems, Inc. Oncology Systems 4D Integrated Treatment Console (4DITC);
All versions up to and including 8.8.17
Varian Medial Systems, Palo Alto, CA
Designed to assist the operator of a radiation device in providing accurate treat Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.