510(k) K020440 ยท DQK Computer, Diagnostic, Programmable
NEWCOR
| Applicant | Siemens Medical Systems, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Dec 3, 2002 |
| Received | Feb 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2017 | Siemens Medical Solutions USA, Inc Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer, Terminated |
DQK | None listed |
| Apr 12, 2017 | Siemens Medical Solutions USA, Inc AXIOM Sensis, Computer, Diagnostic, Programmable.
Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology stu Terminated |
DQK | None listed |
| May 10, 2012 | Siemens Medical Solutions USA, Inc Siemens Axiom Sensis XP diagnostic programmable computer
Diagnostic programmable computer Terminated |
DQK | None listed |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. Terminated |
DQK | None listed |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633. Terminated |
DQK | None listed |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641 Terminated |
DQK | None listed |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658 Terminated |
DQK | None listed |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161 Terminated |
DQK | None listed |
| Sep 14, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 Terminated |
DQK | None listed |
| Jul 3, 2003 | Siemens Medical Solutions USA, Inc Axiom Sensis. Programmable Diagnostic Computer Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.