# K131812: Sensis, Sensis Lite

- Pathway: 510(k) (Special)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Jul 25, 2013 after 36 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910772 (1991). 22 ancestors in all.
2 later devices descend 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)
- K020440: Newcor, Siemens Medical Systems, Inc. (2002) Summary page 2.

## Most influential descendants
- K150493: Sensis (2015), 1 descendant of its own
- K223812: Sensis Vibe (VD15) (2023), 0 descendants of its own

## Indications for use
The Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology 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 intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias. 2. Adult and pediatric populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.

Source page: https://510kreport.com/device/K131812
Methodology: https://510kreport.com/methodology