# K200422: Image Quality Analyzer (IQA)

- Pathway: 510(k) (Traditional)
- Applicant: Visionquest Biomedical, Inc.
- Decided: Dec 24, 2020 after 308 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: 9 generations back to K896095 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181016: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System, Welch Allyn, Inc. (2018) Summary page 4.

## Indications for use
IQA is a software system intended for use in importing, displaying, analyzing and managing images acquired with digital fundus cameras.

Source page: https://510kreport.com/device/K200422
Methodology: https://510kreport.com/methodology