# K143211: myVision Track Model 005

- Pathway: 510(k) (Traditional)
- Applicant: Vital Art and Science Incorporated
- Decided: Mar 20, 2015 after 130 days
- Product code: HOQ (Grid, Amsler)
- 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: 11 generations back to K864318 (1987). 40 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121738: Myvisiontrack (TM), Vital Art and Science Incorporated (2013) Summary page 4.

## Most influential descendants
- K180895: Alleye (2018), 1 descendant of its own
- K203594: EyeCTester (2022), 0 descendants of its own

## Indications for use
The myVisionTrack® Model 0005 is intended for the detection and characterization of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrack® Model 0005 is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

Source page: https://510kreport.com/device/K143211
Methodology: https://510kreport.com/methodology