# K113451: Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EX

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Technologies Srl
- Decided: May 8, 2012 after 169 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941234 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000, Nidek, Inc. (2002) Summary page 2.
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001). Our reading of the summary gave K011977, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Carl Zeiss Meditec FF450 with Fundus Camera and VISUPAC System”.

## Cited in the summary but kept off the family tree
- K070023: Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100, Microsurgeon, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K202097: Fundus Camera (2021), 0 descendants of its own

## Recalls of this device
- Jun 16, 2014 · Class II · Z-1980-2014: Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
- Aug 1, 2013 · Class II · Z-2046-2013: Under certain circumstances, the Left eye image may be saved as the Right eye image.

## Indications for use
The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Source page: https://510kreport.com/device/K113451
Methodology: https://510kreport.com/methodology