510(k) K072485 ยท IYE Accelerator, Linear, Medical
ARTISTE MV SA
| Applicant | Siemens Medical Solutions USA, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 27, 2007 |
| Received | Sep 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2020 | Siemens Medical Solutions USA, Inc ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Terminated |
IYE | None listed |
| 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, 2017 | Siemens Medical Solutions USA, Inc ARTISTE" MV System Terminated |
IYE | None listed |
| Jan 25, 2017 | Siemens 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 |
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 |
| Aug 10, 2014 | Siemens 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 |
IYE | None listed |
| May 23, 2014 | Siemens Medical Solutions USA, Inc Siemens Linear Accelerator (LINAC) models.
Product Usage:
deliver X-ray radiation for therapeutic treatment of cancer 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 |
| Dec 3, 2013 | Siemens 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 |
IYE | None listed |
| Feb 23, 2012 | Siemens 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 |
IYE | None listed |
| Aug 11, 2011 | Siemens 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 |
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 |
| Mar 4, 2011 | Siemens 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 |
IYE | None listed |
| Feb 24, 2011 | Siemens 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 |
IYE | None listed |
| Feb 8, 2011 | Siemens 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 |
IYE | None listed |
| Nov 24, 2010 | Siemens 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 |
IYE | None listed |
| Nov 5, 2009 | Siemens 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 |
IYE | None listed |
| Sep 24, 2009 | Siemens 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 |
IYE | None listed |
| Jan 30, 2009 | Siemens 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 |
IYE | None listed |
| Jan 29, 2009 | Siemens 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 |
IYE | None listed |
| Jan 14, 2009 | Siemens 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 |
IYE | None listed |
| Oct 20, 2008 | Siemens 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 |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.