# K153181: MAIA

- Pathway: 510(k) (Traditional)
- Applicant: Centervue S.P.A.
- Decided: Jun 8, 2016 after 218 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- 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: 7 generations back to K941234 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133758: Centervue Macular Integrity Assessment, Centervue S.P.A. (2014) Summary page 5.
- K061768: MP-1 Microperimeter, Nidek Technologies Srl (2006) Summary page 6.

## Indications for use
The Centervue MAIA is intended for: • measuring macular sensitivity, • measuring fixation stability and the locus of fixation, • providing infrared retinal imaging, and • aiding visual rehabilitation. 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/K153181
Methodology: https://510kreport.com/methodology