# K203594: EyeCTester

- Pathway: 510(k) (Traditional)
- Applicant: Neuro-Eye Diagnostic Systems, LLC
- Decided: Sep 7, 2022 after 637 days
- Product code: QTW (Digital Amsler Grid)
- Device class: 1
- Regulation: 21 CFR 886.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864318 (1987). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180895: Alleye, Oculocare Medical AG (2018) Summary page 5.

## Indications for use
The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central / paracentral visual distortions (maculopathies) as well as central 10-degree visual field scotomas. EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.

Source page: https://510kreport.com/device/K203594
Methodology: https://510kreport.com/methodology