# K181501: Afina

- Pathway: 510(k) (Traditional)
- Applicant: Neurovision Imaging, LLC
- Decided: Nov 2, 2018 after 148 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K012727 (2002). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170638: Retina Workplace, Carl Zeiss Meditec, AG (2017) Summary page 4.

## Indications for use
The Afina software is intended for importing, processing and displaying of retinal images and for the measurement of autofluorescence in the superior field (a circular 50-degree field of view at 20 degrees above fixation) of the retina. Afina is indicated for use only with images collected with validated ophthalmic cameras.

Source page: https://510kreport.com/device/K181501
Methodology: https://510kreport.com/methodology