# K050336: Opd-Station Software

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Aug 24, 2005 after 195 days
- Product code: NCF (Aberrometer, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.1760
- 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 K944207 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944207: Topographic Modeling System 2 TMS-2, Computed Anatomy, Inc. (1994) Summary page 1.
- K003299: Opd-Scan, Models Ark-10000 and Ark-9000, Nidek Co., Ltd. (2001) Summary page 1.

## Indications for use
The OPD-Station software is indicated for use in analyzing the comeal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.

Source page: https://510kreport.com/device/K050336
Methodology: https://510kreport.com/methodology