ClearanceBrief
510(k) K060226 ยท IYE Accelerator, Linear, Medical

ONCOR EXPRESSION

ApplicantSiemens Medical Solutions USA, Inc., Concord CA, US
DecisionSubstantially Equivalent, Mar 15, 2006
ReceivedJan 30, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060226

DateFirm and productCodeLinked 510(k)
Aug 6, 2019Siemens 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
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, 2018Siemens 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
IYENone listed
Feb 14, 2018Siemens 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
IYENone listed
Feb 14, 2017Siemens Medical Solutions USA, Inc
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Terminated
IYENone listed
Jan 25, 2017Siemens 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
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
Mar 18, 2015Siemens 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
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
Dec 3, 2013Siemens 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
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
Apr 26, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
Apr 2, 2013Siemens 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
IYENone listed
May 8, 2012Siemens 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
IYENone listed
May 3, 2012Siemens 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
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
Jan 11, 2012Siemens 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
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
Jul 11, 2011Siemens 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
IYENone listed
May 23, 2011Siemens 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
IYENone listed
May 19, 2011Siemens 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
IYENone listed
May 12, 2011Siemens 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
IYENone listed
Apr 15, 2011Siemens 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
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
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens Medical Solutions USA, Inc
Coherence Therapist System Part number 7339125 Medical charged-particle radiation therapy system.
Terminated
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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, 2008Siemens 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
IYENone listed
Oct 16, 2008Siemens 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
IYENone listed
Sep 29, 2008Siemens 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
IYENone listed
Sep 29, 2008Siemens 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
IYENone listed
Sep 29, 2008Siemens 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
IYENone listed
Sep 29, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 17, 2008Siemens 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
IYENone listed
Sep 4, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 30, 2008Siemens 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
IYENone listed
Apr 2, 2008Siemens 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
IYENone listed
Nov 9, 2007Siemens 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
IYENone listed

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