510(k) K882729 ยท IYE Accelerator, Linear, Medical
MEVATRON, M 2 CLASS
| Applicant | Siemens Medical Laboratories, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Sep 19, 1988 |
| Received | Jul 6, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2020 | Siemens Medical Solutions USA, Inc MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #094017 Terminated |
IYE | None listed |
| Feb 18, 2020 | Siemens Medical Solutions USA, Inc ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Terminated |
IYE | None listed |
| Jan 25, 2017 | Siemens Medical Solutions USA, Inc MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical
The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therap Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M2/PRIMUS Mid;
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 Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron K2;
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 o Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron 77;
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 o Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M 7400/7440 (MXE);
Siemens Healthcare
Concord, CA 94520
Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeu Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron 67;
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 o Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M 6700 (MX);
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 tr Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M 6300 (MX);
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 tr Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M 6730/6740;
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 tr Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron MD (MD, MDX);
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 t Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron KD;
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 o Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron ME;
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 o Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron KD2;
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 Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M2 6300;
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 treatme Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron M2 6740;
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 treatme Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron MD-2;
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 Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron KDS-2;
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 Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron KD-2;
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 Terminated |
IYE | None listed |
| Jan 17, 2012 | Siemens Medical Solutions USA, Inc Mevatron KDS-2;
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 Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, 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 Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, 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 |
| Feb 19, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005; Mevatron M 7140, Part No.: 5694104; Mevatron Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 09401654, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model number 9401746, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9401407, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9401316, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940753, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), MODEL NUMBERS: 8515520 and 9822685, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nels Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401522, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 9411588 and 9822693,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelso Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6300,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401316,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401407,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401506,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401654,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord Terminated |
IYE | None listed |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON MDX-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401746,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concor Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.