# K200954: Glaucoma Module

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Healthcare Solutions, Inc.
- Decided: Aug 3, 2020 after 116 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: 10 generations back to K896095 (1990). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141297: Forum Glaucoma Workplace, Carl Zeiss Meditec, AG (2014) Summary page 4.

## Indications for use
The Glaucoma Module is a software application intended for the management, display and analysis of visual field and optical coherence tomography data. It is intended as an aid to the detection and management of visual field defects and progression of visual field loss.

Source page: https://510kreport.com/device/K200954
Methodology: https://510kreport.com/methodology