# K171098: AXIS Image Management System

- Pathway: 510(k) (Traditional)
- Applicant: Sonomed, Inc.
- Decided: May 2, 2017 after 19 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: 6 generations back to K896095 (1990). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090439: FORUM, Carl Zeiss Meditec, Inc. (2009) Summary page 5.

## Most influential descendants
- K200385: Continuum Pacs (2020), 0 descendants of its own

## Indications for use
Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.

Source page: https://510kreport.com/device/K171098
Methodology: https://510kreport.com/methodology