# K150320: Compass

- Pathway: 510(k) (Traditional)
- Applicant: Centervue S.P.A.
- Decided: Jun 30, 2015 after 141 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: 8 generations back to K941234 (1995). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 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 7.
- K142047: EIDON, Centervue S.P.A. (2014) Summary page 7.
- K954167: Humphrey Field Analyzer (Hfa II), Carl Zeiss, Inc. (1995) Summary page 7.

## Most influential descendants
- K243504: Maia (AHMACME001) (2025), 0 descendants of its own

## Indications for use
The CenterVue COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects.

Source page: https://510kreport.com/device/K150320
Methodology: https://510kreport.com/methodology