# K183059: 3nethra neo

- Pathway: 510(k) (Traditional)
- Applicant: Forus Health Pvt.Ltd
- Decided: Dec 21, 2018 after 49 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K081858 (2008). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102859: Retcam 3 Opthalmic Imaging System, Clarity Medical Systems (2011) Summary page 4.
- K170527: Phoenix Clinical ICON, Phoenix Technology Group, Inc. Dba Phoenix Clinical (2017) Summary page 4.

## Most influential descendants
- K243600: 3nethra neo HD FA; 3nethra neo HD (2025), 0 descendants of its own

## Indications for use
3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.

Source page: https://510kreport.com/device/K183059
Methodology: https://510kreport.com/methodology