# K133758: Centervue Macular Integrity Assessment

- Pathway: 510(k) (Traditional)
- Applicant: Centervue S.P.A.
- Decided: Apr 23, 2014 after 133 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941234 (1995). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092187: Maia, Model 1, Centervue S.P.A. (2010) Summary page 7.

## Most influential descendants
- K150320: Compass (2015), 1 descendant of its own
- K243504: Maia (AHMACME001) (2025), 0 descendants of its own
- K153181: MAIA (2016), 0 descendants of its own

## Indications for use
The Macular Integrity Assessment (MAIAW) is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing Infrared retinal Imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

Source page: https://510kreport.com/device/K133758
Methodology: https://510kreport.com/methodology