510(k) K223812 ยท DQK Computer, Diagnostic, Programmable
Sensis Vibe (VD15)
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 15, 2023 |
| Received | Dec 20, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2024 | Siemens Medical Solutions USA, Inc Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or e Open, Classified |
DQK | None listed |
| Jul 25, 2024 | Siemens Medical Solutions USA, Inc Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as wel Open, Classified |
DQK | None listed |
| Jan 9, 2024 | Siemens Medical Solutions USA, Inc Sensis Vibe Hemo Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.