ClearanceBrief
510(k) K031764 ยท IYE Accelerator, Linear, Medical

ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES

ApplicantSiemens Medical Solutions USA, Inc., Concord CA, US
DecisionSubstantially Equivalent, Sep 5, 2003
ReceivedJun 9, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031764

DateFirm and productCodeLinked 510(k)
Mar 20, 2019Siemens 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
IYENone listed
Feb 14, 2018Siemens 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
IYENone listed
Feb 14, 2017Siemens Medical Solutions USA, Inc
ONCOR" Avant-garde
Terminated
IYENone listed
Jan 25, 2017Siemens 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
IYENone listed
Oct 27, 2015Siemens 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
IYENone listed
Sep 24, 2015Siemens 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
IYENone listed
Feb 5, 2015Siemens 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
IYENone listed
Jan 15, 2015Siemens 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
IYENone listed
Aug 10, 2014Siemens Medical Solutions USA, Inc
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Terminated
IYENone listed
May 21, 2014Siemens 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
IYENone listed
Jul 3, 2013Siemens 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
IYENone listed
Jun 23, 2011Siemens 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
IYENone listed
Apr 13, 2011Siemens 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
IYENone listed
Aug 20, 2008Siemens 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
IYENone listed
Apr 2, 2008Siemens 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
IYENone listed
Dec 1, 2007Siemens 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
IYENone listed
Nov 9, 2007Siemens 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
IYENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.