ClearanceBrief
510(k) K993425 ยท IYE Accelerator, Linear, Medical

PRIMUS

ApplicantSiemens Medical Solutions USA, Inc., Concord CA, US
DecisionSubstantially Equivalent, Nov 26, 1999
ReceivedOct 12, 1999
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K993425

DateFirm and productCodeLinked 510(k)
Feb 18, 2020Siemens Medical Solutions USA, Inc
PRIMUS HI #04504200 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, 2018Siemens Medical Solutions USA, Inc
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 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
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 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
Mevatron M2/Primus Mid-Energy PRIMUS HI
Terminated
IYENone listed
Jan 25, 2017Siemens Medical Solutions USA, Inc
PRIMUS 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 for therapeut
Terminated
IYENone listed
Jan 25, 2017Siemens Medical Solutions USA, Inc
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeu
Terminated
IYENone listed
Jul 26, 2016Siemens Medical Solutions USA, Inc
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
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 26, 2013Siemens Medical Solutions USA, Inc
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, O
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
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 17, 2012Siemens Medical Solutions USA, Inc
PRIMUS HI; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of
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
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTI
Terminated
IYENone listed
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
PRIMUS HI, camera imaging system, Part Number: 4504200; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse,
Terminated
IYENone listed
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentge
Terminated
IYENone listed
Jun 23, 2011Siemens Medical Solutions USA, Inc - Radiation Oncology
ONCOR Impression Plus, camera imaging system, Part Number: 5857912, Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roen
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 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
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Terminated
IYENone listed
Apr 2, 2008Siemens Medical Solutions USA, Inc
Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
Terminated
IYENone listed
Apr 2, 2008Siemens Medical Solutions USA, Inc
Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Conco
Terminated
IYENone listed
Apr 2, 2008Siemens Medical Solutions USA, Inc
Oncor Impression 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, C
Terminated
IYENone listed
Feb 19, 2008Siemens Medical Solutions USA, Inc
Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA
Terminated
IYENone listed
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number :1940035, Siemens Medical Solutions, Concord, CA 94520
Terminated
IYENone listed
Feb 14, 2008Siemens Medical Solutions USA, Inc
Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 4504200, Siemens Medical Solutions, Concord, CA 94520
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 IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave
Terminated
IYENone listed
Nov 9, 2007Siemens Medical Solutions USA, Inc
ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con
Terminated
IYENone listed
Nov 9, 2007Siemens Medical Solutions USA, Inc
MEVATRON M2/PRIMUS Mid,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940035, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Av
Terminated
IYENone listed
Nov 9, 2007Siemens Medical Solutions USA, Inc
PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 4504200,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord,
Terminated
IYENone listed
Jan 6, 2006Siemens Medical Solutions USA, Inc
Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield.
Terminated
IYENone listed

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