510(k) K993425 ยท IYE Accelerator, Linear, Medical
PRIMUS
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Nov 26, 1999 |
| Received | Oct 12, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2020 | Siemens Medical Solutions USA, Inc PRIMUS HI #04504200 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, 2018 | Siemens 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 |
IYE | None listed |
| Feb 14, 2018 | Siemens 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 |
IYE | None listed |
| Feb 14, 2017 | Siemens Medical Solutions USA, Inc Mevatron M2/Primus Mid-Energy
PRIMUS HI Terminated |
IYE | None listed |
| Jan 25, 2017 | Siemens 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 |
IYE | None listed |
| Jan 25, 2017 | Siemens 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 |
IYE | None listed |
| Jul 26, 2016 | Siemens 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 |
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 |
| 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 26, 2013 | Siemens 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 |
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 |
| 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 17, 2012 | Siemens 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 |
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 |
| Jun 23, 2011 | Siemens 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 |
IYE | None listed |
| Jun 23, 2011 | Siemens 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 |
IYE | None listed |
| Jun 23, 2011 | Siemens 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 |
IYE | None listed |
| Jun 23, 2011 | Siemens 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 |
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 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 |
| Sep 29, 2008 | Siemens 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 |
IYE | None listed |
| Apr 2, 2008 | Siemens 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 |
IYE | None listed |
| Apr 2, 2008 | Siemens 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 |
IYE | None listed |
| Apr 2, 2008 | Siemens 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 |
IYE | None listed |
| Feb 19, 2008 | Siemens 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 |
IYE | None listed |
| Feb 14, 2008 | Siemens 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 |
IYE | None listed |
| Feb 14, 2008 | Siemens 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 |
IYE | None listed |
| Dec 1, 2007 | Siemens 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 |
IYE | None listed |
| Nov 9, 2007 | Siemens 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 |
IYE | None listed |
| Nov 9, 2007 | Siemens 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 |
IYE | None listed |
| Nov 9, 2007 | Siemens 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 |
IYE | None listed |
| Nov 9, 2007 | Siemens 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 |
IYE | None listed |
| Jan 6, 2006 | Siemens 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 |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.