# K121738: Myvisiontrack (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Vital Art and Science Incorporated
- Decided: Feb 22, 2013 after 254 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: 10 generations back to K864318 (1987). 39 ancestors in all.
3 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)
- K091579: Foresee Home, Notal Vision, Ltd. (2009) Summary page 5.
- (no number) Amsler Grid: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K053501: Powerpicc, Bard Access Systems, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K143211: myVision Track Model 005 (2015), 2 descendants of its own
- K180895: Alleye (2018), 1 descendant of its own
- K203594: EyeCTester (2022), 0 descendants of its own

## Indications for use
The myVisionTrackTM is intended for the detection and characterization of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated 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 myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

Source page: https://510kreport.com/device/K121738
Methodology: https://510kreport.com/methodology