510(k) K150493 ยท DQK Computer, Diagnostic, Programmable
Sensis
| Applicant | Siemens Medi Cal Solutions, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jun 30, 2015 |
| Received | Feb 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 1, 2023 | Siemens Medical Solutions USA, Inc Programmable Diagnostic Computer Open, Classified |
DQK | None listed |
| Jul 12, 2022 | Siemens Medical Solutions USA, Inc AXIOM Sensis or Sensis Vibe Combo systems as follows:
System Material #
AXIOM Sensis, Combo 64 6623974;
AXIOM Sensis, Hemo LOW 6634633;
AXIOM Sensis, Combo 32 6634641;
AX Terminated |
DQK | None listed |
| Jun 15, 2022 | Siemens Medical Solutions USA, Inc Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology
Mo Open, Classified |
DQK | None listed |
| Jun 15, 2022 | Siemens Medical Solutions USA, Inc Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Rad Open, Classified |
DQK | None listed |
| Jun 6, 2022 | Siemens Medical Solutions USA, Inc Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633
6634658 6648153
6648161 10140973
10764561 1076550 Open, Classified |
DQK | None listed |
| Jan 14, 2022 | Siemens Medical Solutions USA, Inc 1. Sensis, material # 10764561; UDI: 04056869010137
2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199
3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205
The Sensis reco Open, Classified |
DQK | None listed |
| Oct 5, 2021 | Siemens Medical Solutions USA, Inc Sensis/ Sensis Vibe systems with software VD1X as follows:
(1)Sensis Model 10764561
(2) Sensis Vibe Hemo Model 11007641
(3)Sensis Vibe Combo Model 11007642
Intended Use: A diagnostic and administr Open, Classified |
MUQ | None listed |
| Apr 19, 2021 | Siemens Medical Solutions USA, Inc Sensis/ Sensis Vibe Hemo systems with VD12A software as follows:
Dedicated SIS Server- 6648153
Sensis Post-Processing Workstation- 6648161
Sensis- 10764561
VM Virtual Server- 10765502
Sensis High-End Terminated |
DQK | None listed |
| Jan 27, 2021 | Siemens Medical Solutions USA, Inc Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Terminated |
DQK | None listed |
| Aug 28, 2020 | Siemens Medical Solutions USA, Inc Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac Terminated |
DQK | None listed |
| Nov 29, 2018 | Siemens Medical Solutions USA, Inc Sensis Vibe System, Model Number 11007642, with software version VD10B. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.