# K203244: CellChek 20 rc

- Pathway: 510(k) (Traditional)
- Applicant: Konan Medical, Inc.
- Decided: Jun 15, 2021 after 224 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- 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: 4 generations back to K905070 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081797: Image Storage System, Model KSS-400, Konan Medical, Inc. (2009) Summary page 4.

## Indications for use
The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.

Source page: https://510kreport.com/device/K203244
Methodology: https://510kreport.com/methodology