510(k) K060226 ยท IYE Accelerator, Linear, Medical
ONCOR EXPRESSION
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Mar 15, 2006 |
| Received | Jan 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2019 | Siemens Medical Solutions USA, Inc Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. 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, 2018 | Siemens Medical Solutions USA, Inc ONCOR Expression, Digital Linear Accelerator, Model No. 07360717
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, 2018 | Siemens Medical Solutions USA, Inc ONCOR Impression , Digital Linear Accelerator, Model No. 05857920
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" Expression
ONCOR" Impression
ONCOR" Impression plus Terminated |
IYE | None listed |
| Jan 25, 2017 | Siemens Medical Solutions USA, Inc ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system
Product Usage:
The intended use of the SIEMENS branded PRIMUS family of linear accelera 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 |
| Mar 18, 2015 | Siemens Medical Solutions USA, Inc ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software.
The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of c 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 |
| Dec 3, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand ONCOR series 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 accelera 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 |
| Apr 26, 2013 | Siemens Medical Solutions USA, Inc Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108
on Siemens ARTISTE, ONCOR and PRIMUS systems.
ARTISTE, ONCOR and PRIMUS family of l Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE AG T Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH, Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE Impre Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
COHERENCE TH 2. Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i, P Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i 2 Terminated |
IYE | None listed |
| Apr 2, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;
Model:
Primeview 3i 2 Terminated |
IYE | None listed |
| May 8, 2012 | Siemens Medical Solutions USA, Inc Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system;
Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PR Terminated |
IYE | None listed |
| May 3, 2012 | Siemens Medical Solutions USA, Inc Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table 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 |
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc ARTISTE and ONCOR linear accelerators with G31 mother board.
ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany.
ARTISTE, ONCOR and PRIMUS famil 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 |
| Jul 11, 2011 | Siemens Medical Solutions USA, Inc ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS.
The Linear Accelerators are used to deliver X-ray photon and elec Terminated |
IYE | None listed |
| May 23, 2011 | Siemens Medical Solutions USA, Inc ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system;
Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS.
The ONCOR and PRIMUS Terminated |
IYE | None listed |
| May 19, 2011 | Siemens Medical Solutions USA, Inc ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2.
The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 soft Terminated |
IYE | None listed |
| May 12, 2011 | Siemens Medical Solutions USA, Inc ARTISTE / RT Therapist v4.1 system.
The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software.
Siemens Healthcare, Concord, CA.
The intended use is to deliver X-ray photon Terminated |
IYE | None listed |
| Apr 15, 2011 | Siemens Medical Solutions USA, Inc Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is manufactured by IMPAC Medical, Inc., Sunnyvale, C 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 |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Coherence Therapist System Part number 7339125
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341410
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341428
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345411
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345429
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345437
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847
Medical charged-particle radiation therapy system. Terminated |
None listed | |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147675
Medical charged-particle radiation therapy system. Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5857912 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system Part number 7339125, equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1. This is a medical cha Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part number 7341410. Medical charged particle Radiation therapy system Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428. Medical charged particle Radiation therapy system, part of the fir Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - AG Therapist 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345411. Medical charged particle Radiation therapy system, part of th Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Impression Therapist 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345429. Medical charged particle Radiation therapy system, pa Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345437. Medical charged particle Radiation therapy system, part Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839. Medical charged particle Radiation therapy system, part of the f Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847. Medical charged particle Radiation therapy system, part of the f Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147667. Medical charged particle Radiation therapy system, part o Terminated |
IYE | None listed |
| Sep 17, 2008 | Siemens Medical Solutions USA, Inc Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged particle Radiation therapy system, part of the f Terminated |
IYE | None listed |
| Sep 4, 2008 | Siemens Medical Solutions USA, Inc Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506, 7339125, 7341410, 7341428, 7345411, 7345429, 7345437, 8139839, 8139847, 81476 Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 30, 2008 | Siemens Medical Solutions USA, Inc Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i. Siemens AG, Concord, CA. Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Oncor Expression Medical Linear Accelerator, Material Number: 07360717, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, C Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc ONCOR Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 7360204 and 7360717, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Ne Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.