510(k) K031764 ยท IYE Accelerator, Linear, Medical
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Sep 5, 2003 |
| Received | Jun 9, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2019 | Siemens Medical Solutions USA, Inc Siemens Digital Linear Accelerators of type:
ARTISTE MV System
MEVATRON M2/Primus Mid-Energy PRIMUS
PRIMUS HI
ONCOR Impression
ONCOR Impression Plus
ONCOR Avant Garde
ONCOR Expression
ARTISTE, ONCOR, Terminated |
IYE | None listed |
| Feb 14, 2018 | Siemens Medical Solutions USA, Inc ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472
Product Usage:
The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Terminated |
IYE | None listed |
| Feb 14, 2017 | Siemens Medical Solutions USA, Inc ONCOR" Avant-garde Terminated |
IYE | None listed |
| Jan 25, 2017 | Siemens Medical Solutions USA, Inc ONCOR Avant-garde, medical charged-particle radiation therapy system
Product Usage:
The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation f Terminated |
IYE | None listed |
| Oct 27, 2015 | Siemens Medical Solutions USA, Inc ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of Terminated |
IYE | None listed |
| Sep 24, 2015 | Siemens Medical Solutions USA, Inc ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer
Product Usage:
The intended use of the SIEMENS branded AR Terminated |
IYE | None listed |
| Feb 5, 2015 | Siemens Medical Solutions USA, Inc LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI,
Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2,
MEVATRON K Terminated |
IYE | None listed |
| Jan 15, 2015 | Siemens Medical Solutions USA, Inc Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KD Terminated |
IYE | None listed |
| Aug 10, 2014 | Siemens Medical Solutions USA, Inc Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option. Terminated |
IYE | None listed |
| May 21, 2014 | Siemens Medical Solutions USA, Inc 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC)
To deliver X-ray radiation for therapeutic treatment of cancer. Terminated |
IYE | None listed |
| Jul 3, 2013 | Siemens Medical Solutions USA, Inc Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability.
The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" Terminated |
IYE | None listed |
| Jun 23, 2011 | Siemens Medical Solutions USA, Inc - Radiation Oncology ONCOR Avant Garde , camera imaging system, Part Number:5863472;
Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS
Roentge Terminated |
IYE | None listed |
| Apr 13, 2011 | Siemens Medical Solutions USA, Inc LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Terminated |
IYE | None listed |
| Aug 20, 2008 | Siemens Medical Solutions USA, Inc Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therap Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, Terminated |
IYE | None listed |
| Dec 1, 2007 | Siemens Medical Solutions USA, Inc Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5863472,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.