# K973533: Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF)

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Nov 4, 1997 after 47 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.
37 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991284: Anterior Eye-Segment Analysis System (1999), 33 descendants of its own
- K030719: Pentacam Scheimpflug Camera (2003), 18 descendants of its own
- K012873: Documenting Laser Slit Lamp, DP 2010 (2001), 18 descendants of its own
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter (2003), 16 descendants of its own
- K082891: Lenstar, Model LS900 (2009), 14 descendants of its own

## Indications for use
Model 3-DX captures simultaneous stereo photographs of disc/fundus area on a single frame - suitable picture angle for stereoscopic optic disc glaucoma diagnosis. Model 3-DXF has an additional fluorescence angiography capability to 3-DX.

Source page: https://510kreport.com/device/K973533
Methodology: https://510kreport.com/methodology