# K243664: Sentinel Camera

- Pathway: 510(k) (Traditional)
- Applicant: Ai Optics
- Decided: Dec 17, 2024 after 20 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 K003376 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module, Optomed OY (2018) Summary page 5.

## Indications for use
Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.

Source page: https://510kreport.com/device/K243664
Methodology: https://510kreport.com/methodology