# K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Optimed, Inc.
- Decided: Dec 1, 1995 after 45 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
No predicates in its family tree.
40 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K043213: Kowa VX-10 (2005), 31 descendants of its own
- K090115: Retina Camera TRC-NW7SF Mark II (2009), 30 descendants of its own
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F (2010), 28 descendants of its own
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K123460: TRC-NW300 Non-Mydriatic Retinal Camera (2013), 11 descendants of its own

Source page: https://510kreport.com/device/K954780
Methodology: https://510kreport.com/methodology