510(k) K862339 ยท IYE Accelerator, Linear, Medical
MEVATRON KD-2
| Applicant | Siemens Medical Laboratories, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Oct 29, 1986 |
| Received | Jun 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2017 | Siemens Medical Solutions USA, Inc MEVATRON KD-2, accelerator, Linear, Medical
The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer Terminated |
IYE | None listed |
| Jun 23, 2011 | Siemens Medical Solutions USA, Inc - Radiation Oncology Mevatron K2, camera imaging system, Part Number: 1940753;
Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS
Roentgenstrass Terminated |
IYE | None listed |
| Jun 23, 2011 | Siemens Medical Solutions USA, Inc - Radiation Oncology MEVATRONKD, camera imaging system, Part Number: 8319857;
Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS
Roentgenstrass Terminated |
IYE | None listed |
| Jun 23, 2011 | Siemens Medical Solutions USA, Inc - Radiation Oncology MEVATRONKD-2, camera imaging system, Part Number: 8515520;
Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS
Roentgenstras Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 8515520 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 KDS-2 Digital Linear Accelerator, part number 9411588 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 Me Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 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 KDS-2 Digital Linear Accelerator, part number 9822693 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 Me Terminated |
IYE | None listed |
| Sep 29, 2008 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 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 M2/ Primus Mid Digital Linear Accelerator, part number 1940035 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energ Terminated |
IYE | None listed |
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, 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: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.