# K132987: Cobra Fundus Camera

- Pathway: 510(k) (Traditional)
- Applicant: C.S.O. S.R.L.
- Decided: Jul 3, 2014 after 282 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 K941234 (1995). 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)
- K101628: Kowa Nonmyd WX, Kowa Co., Ltd. (2011) Summary page 1.

## Indications for use
The CSQ Cobra Fundus Camera is intended for taking digital images of a human retina with or without the use of mydriatic agent. The retinal image can be stored to an image filing device.

Source page: https://510kreport.com/device/K132987
Methodology: https://510kreport.com/methodology