ClearanceBrief
510(k) K072485 ยท IYE Accelerator, Linear, Medical

ARTISTE MV SA

ApplicantSiemens Medical Solutions USA, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Dec 27, 2007
ReceivedSep 4, 2007
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K072485

DateFirm and productCodeLinked 510(k)
Feb 18, 2020Siemens Medical Solutions USA, Inc
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Terminated
IYENone listed
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, 2017Siemens Medical Solutions USA, Inc
ARTISTE" MV System
Terminated
IYENone listed
Jan 25, 2017Siemens Medical Solutions USA, Inc
ARTISTE MV System, 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
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
Aug 10, 2014Siemens Medical Solutions USA, Inc
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator s
Terminated
IYENone listed
May 23, 2014Siemens Medical Solutions USA, Inc
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
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
Dec 3, 2013Siemens Medical Solutions USA, Inc
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator
Terminated
IYENone listed
Feb 23, 2012Siemens Medical Solutions USA, Inc
ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to deliver X-ray, photon and electron radiation
Terminated
IYENone listed
Aug 11, 2011Siemens Medical Solutions USA, Inc
ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators
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
Mar 4, 2011Siemens Medical Solutions USA, Inc
Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Co
Terminated
IYENone listed
Feb 24, 2011Siemens Medical Solutions USA, Inc., Concord, CA
Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver x-ray radiation for therapeutic treatment
Terminated
IYENone listed
Feb 8, 2011Siemens Medical Solutions USA, Inc
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version N
Terminated
IYENone listed
Nov 24, 2010Siemens Medical Solutions USA, Inc
Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufact
Terminated
IYENone listed
Nov 5, 2009Siemens Medical Solutions USA, Inc
Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA
Terminated
IYENone listed
Sep 24, 2009Siemens Medical Solutions USA, Inc
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 o
Terminated
IYENone listed
Jan 30, 2009Siemens Medical Solutions USA, Inc
Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA Medical charged-particle radiation the
Terminated
IYENone listed
Jan 29, 2009Siemens Medical Solutions USA, Inc
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
Terminated
IYENone listed
Jan 14, 2009Siemens Medical Solutions USA, Inc
Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical S
Terminated
IYENone listed
Oct 20, 2008Siemens Medical Solutions USA, Inc
Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for
Terminated
IYENone listed

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