# K043222: Viscucam C Digital Camera

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Feb 14, 2005 after 84 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: 2 generations back to K941234 (1995). 4 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021787: Visucam, Carl Zeiss Ophthalmic Systems, Inc. (2002) Summary page 4.
- K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM, Canon USA, Inc. (1998) Summary page 4.

## Most influential descendants
- K052268: Visucam Pro NM (2005), 21 descendants of its own
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K150467: Retina Workplace (2015), 3 descendants of its own
- K133217: Cirrus Photo (2014), 3 descendants of its own

## Indications for use
The VISUCAM C Digital Camera is intended for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.

Source page: https://510kreport.com/device/K043222
Methodology: https://510kreport.com/methodology