# K192890: SentEP

- Pathway: 510(k) (Traditional)
- Applicant: Sentiar, Inc.
- Decided: Sep 18, 2020 after 344 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K924630 (1993). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173274: Ceevra Reveal 2.0, Ceevra, Inc. (2018) Summary page 4.

## Most influential descendants
- K223290: CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) (2023), 0 descendants of its own

## Indications for use
The SentEP system is intended for use as a medical imaging system that allows the review, analysis, communication, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. The SentEP system is designed as an additional visualization modality to assist the clinician. The SentEP system is indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.

Source page: https://510kreport.com/device/K192890
Methodology: https://510kreport.com/methodology