# K153239: LSFG-Navi

- Pathway: 510(k) (Traditional)
- Applicant: Softcare Co., Ltd.
- Decided: May 12, 2016 after 185 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: 3 generations back to K943955 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062416: Retinal Functional Imager (Rfi), Optical Imaging, Ltd. (2006) Summary page 6.

## Indications for use
The LSFG-NAVI system is intended to capture and display the blood flow distribution in the human retina in real time, and to monitor the blood flow in retinal vessels for their quantitative evaluation.

Source page: https://510kreport.com/device/K153239
Methodology: https://510kreport.com/methodology