# K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Jena GmbH
- Decided: Sep 26, 2001 after 103 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.
83 later devices descend from it; 8 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IMAGEnet Digital Ophthalmic Imaging System: named in the summary without a submission number
- (no number) ImageScape Digital Retinal Imaging System: named in the summary without a submission number

## Most influential descendants
- K021787: Visucam (2002), 74 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
- 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

## Indications for use
The FF450 rlus VISUPAC system is intended to capture, display, store, and manipulate 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/K011877
Methodology: https://510kreport.com/methodology