# K946058: 60 Fundus Camera CF-60UV

- Pathway: 510(k) (Traditional)
- Applicant: Canon USA, Inc.
- Decided: Feb 3, 1995 after 87 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.
93 later devices descend from it; 2 cite it directly.
0 of 94 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
- K041546: Digital Fundus Camera, Model CF-60DSI (2004), 80 descendants of its own
- K062295: Iri Integrated Retinal Imager (2006), 63 descendants of its own
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), 41 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

Source page: https://510kreport.com/device/K946058
Methodology: https://510kreport.com/methodology