# K991284: Anterior Eye-Segment Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Aug 6, 1999 after 113 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- 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 K955442 (1996). 2 ancestors in all.
33 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973533: Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF), Nidek, Inc. (1997) Summary page 1.
- K955442: Kowa SC-1200 Photo Slit Lamp System, Kowa Optimed, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K101182: Iolmaster 500 (2010), 10 descendants of its own

## Indications for use
The EAS-1000 “Anterior Eye-Segment Analysis System” is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.

Source page: https://510kreport.com/device/K991284
Methodology: https://510kreport.com/methodology