# K013694: Nidek Advanced Vision Information System (Navis)

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Nov 19, 2002 after 377 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 K896095 (1990). 7 ancestors in all.
61 later devices descend from it; 7 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012093: Aetmed Image Processing Software, Aetmed, S.P.A. (2001)

## Most influential descendants
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for (2008), 50 descendants of its own
- K090439: FORUM (2009), 32 descendants of its own
- K093313: Synergy (2009), 29 descendants of its own
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own
- K101861: Truevision 3D Visualization and Guidance System (2010), 13 descendants of its own

## Indications for use
The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.

Source page: https://510kreport.com/device/K013694
Methodology: https://510kreport.com/methodology