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Nidek US-2000

by Nidek, Inc.

510(k) K903326

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903326 Date21 Nov 1990ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IYO
Device class
Class II
Regulation
21 CFR Part 892.1560
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

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