# K050350: The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)

- Pathway: 510(k) (Traditional)
- Applicant: Notal Vision, Inc.
- Decided: Apr 29, 2005 after 77 days
- Product code: HPT (Perimeter, Automatic, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1605
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K841099 (1984). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954167: Humphrey Field Analyzer (Hfa II), Carl Zeiss, Inc. (1995) Summary page 2.
- K841099: Octopus 500/500E, Cilco, Inc. (1984) Summary page 2.
- K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C), Heidelberg Engineering (1997) Summary page 2.
- K014044: Mascular Computerized Psychophysical Test (MCPT), Notal Vision, Inc. (2002) Summary page 2.
- (no number) Amsler Grid: named in the summary without a submission number

## Most influential descendants
- K091579: Foresee Home (2009), 4 descendants of its own
- K121738: Myvisiontrack (TM) (2013), 3 descendants of its own
- 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 PreView Preferential Hyperacuity Perimeter (PreView PHPTM) is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

Source page: https://510kreport.com/device/K050350
Methodology: https://510kreport.com/methodology