# K132323: RS-3000 Advance

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Feb 19, 2014 after 209 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K012727 (2002). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121622: Nidek RS-3000, Nidek Co., Ltd. (2013) Summary page 2.

## Indications for use
The Nidek Optical Coherence Tomography RS-3000 Advance, including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of: * the retina, retinal nerve fiber layer, and optic disc, and * the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter), as an aid in the diagnosis and management of adults having or suspected of having ocular disease.

Source page: https://510kreport.com/device/K132323
Methodology: https://510kreport.com/methodology