# Nidek US-2000

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/nidek-us-2000-iyo>
- Manufacturer: [Nidek, Inc.](https://devicerts.com/manufacturers/nidek-inc) (United States, FDA 510(k) applicant)
- Name in the registry: NIDEK US-2000
- Device class: Class II (US FDA)
- FDA product code: IYO

## Overview

*AI-generated summary, 2026-09-23. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Nidek US-2000 is an ultrasound imaging system used in radiology for diagnostic imaging procedures. It is designed to produce real-time ultrasound images for clinical evaluation.

The device is supplied as a reusable system intended for use in clinical settings such as hospitals and imaging centers. It requires appropriate cleaning and maintenance between uses and is not designated as sterile or single-use. The system operates under FDA 510(k) clearance (K903326) and is authorized for marketing in the United States.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K903326 · decision 1990-11-21 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K903326 [FDA 510(k)]
- FDA product code: IYO [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1560 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Nidek US-2000, Nidek, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/nidek-us-2000-iyo (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/nidek-us-2000-iyo.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/nidek-us-2000-iyo
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.