# K201162: Essence 55SP Large Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Shenyang Torch-Bigtide Digital Technology Co., Ltd.
- Decided: Aug 27, 2020 after 119 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K941811 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172969: Essence 55S Large Monitor System, Shenyang Torch-Bigtide Digital Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
The Essence 55SP Large Monitor System (Essence 55SP) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.

Source page: https://510kreport.com/device/K201162
Methodology: https://510kreport.com/methodology