# K181345: Image Filing Software NAVIS-EX

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Jul 19, 2018 after 59 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: 8 generations back to K896095 (1990). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match, Carl Zeiss Meditec, AG (2012) Summary page 4.

## Most influential descendants
- K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (2023), 0 descendants of its own

## Indications for use
The Image Filing Software NAVIS -EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Source page: https://510kreport.com/device/K181345
Methodology: https://510kreport.com/methodology