# K172817: 4K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EA

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 17, 2017 after 29 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: 10 generations back to K931154 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151011: Visera 4K Uhd System, Olympus Medical Systems Corp. (2015) Summary page 5.

## Indications for use
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

Source page: https://510kreport.com/device/K172817
Methodology: https://510kreport.com/methodology