# K021787: Visucam

- Pathway: 510(k) (Special)
- Applicant: Carl Zeiss Ophthalmic Systems, Inc.
- Decided: Jun 21, 2002 after 22 days
- Product code: NFF (Device, Storage, Images, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011877 (2001). 1 ancestor in all.
74 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001)

## Most influential descendants
- 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
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan (2009), 22 descendants of its own
- K043222: Viscucam C Digital Camera (2005), 22 descendants of its own

## Indications for use
The VISUCAMlite Fundus Camera is intended to capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Source page: https://510kreport.com/device/K021787
Methodology: https://510kreport.com/methodology