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Xario 100 Diagnostic Ultrasound System V5.0

by Toshibamedical Systems Corporation

510(k) K162187

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK162187 Date30 Sep 2016ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2708-2017 FDA Class II initiated 1 May 2017

    When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

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  • Withdrawn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, 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 Xario 100 Diagnostic Ultrasound System V5.0 is a diagnostic ultrasound system designed for medical imaging applications. It utilizes ultrasound technology to produce diagnostic images for clinical evaluation.

This device is supplied by Toshibamedical Systems Corporation and has received FDA 510K clearance. It is categorized under the radiology advisory committee for regulatory purposes.

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Questions

AI-generated answers, 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.

  • What is the primary function of the Xario 100 Diagnostic Ultrasound System?

    The Xario 100 is a diagnostic ultrasound system engineered to produce medical images. It is intended to be used by clinicians to perform diagnostic imaging applications for the purpose of clinical evaluation.

  • What is the regulatory status of this ultrasound system?

    The Xario 100 Diagnostic Ultrasound System, V5.0, has received FDA 510K clearance. It was reviewed under the radiology advisory committee and determined to be substantially equivalent to existing devices.

  • Who is the manufacturer of the Xario 100 system?

    This device is manufactured by Toshibamedical Systems Corporation, located in Otawara-Shi, Japan. The system is identified by the K-number K162187.