# K081797: Image Storage System, Model KSS-400

- Pathway: 510(k) (Traditional)
- Applicant: Konan Medical, Inc.
- Decided: Jan 22, 2009 after 211 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: 3 generations back to K905070 (1991). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980357: Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter, Konan, Inc. (1998) Summary page 1.
- K992354: SNT Image Analysis System, Surgical Navigation Technologies, Inc. (1999) Summary page 1.
- K062763: Noncon Robo Pachy F&a, Konan Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K203244: CellChek 20 rc (2021), 0 descendants of its own

## Indications for use
The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes

Source page: https://510kreport.com/device/K081797
Methodology: https://510kreport.com/methodology