# K150493: Sensis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Jun 30, 2015 after 125 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910772 (1991). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131812: Sensis, Sensis Lite, Siemens Medi Cal Solutions, Inc. (2013) Summary page 5.
- K002137: Cathcor Desktop, Siemens Elema AB (2000) Summary page 5.

## Most influential descendants
- K223812: Sensis Vibe (VD15) (2023), 0 descendants of its own

## Recalls of this device
- Nov 16, 2022 · Class II · Z-0775-2023: The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" err
- Jul 12, 2022 · Class III · Z-1558-2022: The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the 
- Jun 15, 2022 · Class II · Z-1426-2022: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe
- Jun 15, 2022 · Class II · Z-1425-2022: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe
- Apr 13, 2022 · Class II · Z-1243-2022: Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on th
- Nov 23, 2021 · Class II · Z-0499-2022: Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipmen
- Oct 5, 2021 · Class II · Z-0226-2022: System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rar
- Mar 4, 2021 · Class II · Z-1434-2021: Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of
- Jan 27, 2021 · Class II · Z-1173-2021: System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
- Jul 24, 2020 · Class II · Z-2921-2020: The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditio
- Nov 29, 2018 · Class II · Z-0936-2019: A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without 

## Indications for use
The Sensis recording system is 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. The system is equipped by modules, enabling various configurations ranging from a stand-alone 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/K150493
Methodology: https://510kreport.com/methodology