510(k) K093527 ยท IYE Accelerator, Linear, Medical
ARIA RADIATION ONCOLOGY WITH MIRS
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Dec 15, 2009 |
| Received | Nov 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093527
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2015 | Varian Medical Systems, Inc. ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License.
Model number HIT
Product Usage:
ARIA Radiation Oncology is a radiation treatment plan and image managemen Terminated |
MUJ | None listed |
| Dec 20, 2013 | Varian Medical Systems, Inc. Plan Parameters workspace within
Eclipse Treatment Planning System Version 11 and 13;
ARIA Radiation Oncology versions 11 and 13
Acuity, versions 11 and 13.
Manufactured by Varian Medical Systems
Pal Terminated |
MUJ | None listed |
| Dec 17, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0. Terminated |
IYE | None listed |
| Nov 1, 2012 | Varian Medical Systems, Inc. Oncology Systems ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. Terminated |
IYE | None listed |
| Aug 8, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Varian ARIA Oncology Information System, Import Export
application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medic Terminated |
IYE | None listed |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., P Terminated |
IYE | None listed |
| Jul 8, 2011 | Varian Medical Systems, Inc. Oncology Systems ARIA, versions 8.0 and 8.1;
Varian Medical Systems, Palo Alto, CA.
Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to e Terminated |
IYE | None listed |
| May 2, 2011 | Varian Medical Systems, Inc. Oncology Systems ARIA, RT Chart Application v 8.0 through 8.9
Varian Medical Systems, Palo Alto, CA.
Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized use Terminated |
IYE | None listed |
| Apr 7, 2011 | Varian Medical Systems, Inc. Oncology Systems ARIA versions 8.0 and 8.1
Varian Medical Systems, Palo Alto, CA 94304
The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.