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Accuvix XQ Diagnostic Ultrasound System

by Medison Co., Ltd.

510(k) K052911

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052911 Date31 Oct 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Accuvix XQ Diagnostic Ultrasound System is a diagnostic imaging device classified as an ultrasound machine, designed for real-time visualization of internal body structures using high-frequency sound waves. It incorporates Doppler capabilities, including color and spectral Doppler, to assess blood flow and tissue perfusion, supporting a range of diagnostic applications. The system is engineered to generate 2D, 3D, and 4D imaging for comprehensive anatomical and functional evaluations.

This ultrasound system is intended for use in clinical settings such as radiology departments, obstetrics/gynecology, and vascular diagnostics. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate imaging performance. The Accuvix XQ holds FDA 510(k) clearance under the traditional review pathway, with a classification under product code IYN (Ultrasound Imaging Systems). No specific sterility or single-use designation is indicated in the regulatory data.

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