# K223812: Sensis Vibe (VD15)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 15, 2023 after 269 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003122 (2001). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150493: Sensis, Siemens Medi Cal Solutions, Inc. (2015) Summary page 4.
- K191008: iLab Polaris Multi-Modality Guidance System, Boston Scientific Corporation (2019) Summary page 5.

## Recalls of this device
- Jul 3, 2024 · Class II · Z-2438-2024: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that th
- Jul 3, 2024 · Class II · Z-2441-2024: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that th
- Nov 29, 2023 · Class II · Z-0683-2024: The possibility of the Sensis documentation functionality application to crash.

## Indications for use
The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative tools. The device is intended to be used on either or both of the following populations: 1. Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias. 2. Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.

Source page: https://510kreport.com/device/K223812
Methodology: https://510kreport.com/methodology