# K250204: Endoscopic Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sophway Technology Co., Ltd.
- Decided: Jul 1, 2025 after 158 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944620 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160044: Image1 SPIES System, Karl Storz Endoscopy America, Inc. (2016) Summary page 6.

## Indications for use
Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

Source page: https://510kreport.com/device/K250204
Methodology: https://510kreport.com/methodology