510(k) K013826 ยท KPR System, X-Ray, Stationary
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
| Applicant | Siemens Medical Systems, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Nov 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Siemens Medical Solutions USA, Inc System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MP Terminated |
KPR | None listed |
| May 5, 2015 | Siemens Medical Solutions USA, Inc AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/scr Terminated |
KPR | None listed |
| Apr 12, 2011 | Siemens Medical Solutions USA, Inc Axiom Aristos FX and FX Plus System
Intended use: Stationary x-ray system Terminated |
KPR | None listed |
| Oct 20, 2008 | Siemens Medical Solutions USA, Inc Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803. Terminated |
KPR | None listed |
| Jul 13, 2005 | Siemens Medical Solutions USA, Inc Axiom Aristos TX. Model number 58 94 873
Radiology system Terminated |
KPR | None listed |
| Jul 13, 2005 | Siemens Medical Solutions USA, Inc Axiom Aristos MX/VX. Model number 58 95 003 Terminated |
KPR | None listed |
| Jul 13, 2005 | Siemens Medical Solutions USA, Inc Axiom Aristos FX. Model number 74 14 803 Terminated |
KPR | None listed |
| Jul 8, 2003 | Siemens Medical Solutions USA, Inc Axiom Aristos X-Ray System. Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.