# K181016: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Jul 16, 2018 after 90 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
- K200422: Image Quality Analyzer (IQA) (2020), 0 descendants of its own

## Indications for use
The Welch Allyn RetinaVue Network is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments. Original and enhanced images can be viewed by trained healthcare professionals.

Source page: https://510kreport.com/device/K181016
Methodology: https://510kreport.com/methodology