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Xario 100, V3.0

by Toshibamedical Systems Corporation

510(k) K143046

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 NumberK143046 Date19 Nov 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2542-2016 FDA Class II initiated 4 Aug 2016

    Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.

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  • Withdrawn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, 19 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, V3.0 is a diagnostic ultrasound system classified under product code IYN, designed for visualizing internal body structures and dynamic physiological processes using ultrasound imaging. It provides real-time diagnostic information for clinical applications such as fetal, abdominal, and intraoperative assessments.

This device is supplied as a reusable Class II medical system, intended for use in radiology settings. It holds an FDA 510(k) clearance under the Traditional review pathway, with a clearance date of November 19, 2014, and is manufactured by Toshiba Medical Systems Corporation. No specific sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 19 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 clinical applications is the Xario 100, V3.0 primarily used for in a hospital setting?

    The Xario 100, V3.0 is designed for real-time ultrasound imaging to visualize internal body structures and physiological processes. It is particularly suited for clinical assessments like fetal monitoring, abdominal scans, and intraoperative guidance, providing diagnostic information for these specific applications in radiology settings.

  • Is the Xario 100, V3.0 intended for single-use or reusable in a clinical environment?

    The Xario 100, V3.0 is classified as a reusable Class II medical system, meaning it is engineered for repeated use in radiology departments after proper cleaning and maintenance. No sterility information is provided, so adherence to manufacturer guidelines for reprocessing is essential.

  • How was the FDA clearance for the Xario 100, V3.0 determined, and what does that mean for its regulatory status?

    The Xario 100, V3.0 received FDA clearance under the Traditional review pathway, specifically determined to be *substantially equivalent* to a legally marketed predicate device. This means the FDA evaluated it against an existing ultrasound system and found it to have the same intended use and technological characteristics, confirming its safety and effectiveness for diagnostic imaging applications.

  • What type of facility or department would typically use the Xario 100, V3.0?

    The Xario 100, V3.0 is explicitly intended for use in radiology departments, where ultrasound imaging is performed. Its design aligns with diagnostic settings requiring real-time visualization of internal structures, such as obstetrics, abdominal, and intraoperative assessments.