Sensis Vibe (VD15)— 510(k) K223812
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K223812 for Sensis Vibe (VD15), Substantially Equivalent on 2023-09-15. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code DQK
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K223812
K-number listed on FDA's recall record- Z-2438-2024 — 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 electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 10910620
- Z-2441-2024 — 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 well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 11007641
- Z-0683-2024 — Sensis Vibe Hemo
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223812.
Data sourced from openFDA. This site is unofficial and independent of the FDA.