510(k) K982502 ยท IYE Accelerator, Linear, Medical
GENESIS IMRT LINEAR ACCELERATOR
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Jul 31, 1998 |
| Received | Jul 20, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Aug 10, 2014 | Siemens Medical Solutions USA, Inc Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option. 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 |
| Jun 23, 2011 | Siemens Medical Solutions USA, Inc - Radiation Oncology MEV ATRON PRIMART, camera imaging system, Part Number: 5500371;
Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS
Roentgen Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.