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Xario 200, V3.0

by Toshibamedical Systems Corporation

510(k) K143027

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 NumberK143027 Date20 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  • Withdrawn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, 21 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 200, V3.0 is a diagnostic ultrasound system used for the visualization of structures and dynamic processes within the human body. It provides image information for diagnosis in various clinical applications, including fetal, abdominal, intra-operative, and laparoscopic procedures. The device operates using ultrasound technology to produce images for diagnostic purposes.

The Xario 200, V3.0 is supplied as a Class 2 Radiology device with product code IYN. It has been cleared through the Traditional 510(k) pathway and is authorized by the FDA. The device is available in model numbers TUS-X200 and TUS-X200S, and its storage and handling requirements are not specified. The Xario 200, V3.0 is intended for use in diagnostic procedures, and its regulatory status is Substantially Equivalent, as determined by the FDA on November 20, 2014.

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Questions

AI-generated answers, 21 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 Xario 200, V3.0 used for?

    The Xario 200, V3.0 is used for diagnostic purposes, providing image information for diagnosis in various clinical applications, including fetal, abdominal, intra-operative, and laparoscopic procedures.

  • How is the Xario 200, V3.0 supplied?

    The Xario 200, V3.0 is supplied as a Class 2 Radiology device with product code IYN, available in model numbers TUS-X200 and TUS-X200S.

  • What is the regulatory status of the Xario 200, V3.0?

    The Xario 200, V3.0 has been cleared through the Traditional 510(k) pathway and is authorized by the FDA, with a regulatory status of Substantially Equivalent, as determined by the FDA on November 20, 2014.

  • What are the storage and handling requirements for the Xario 200, V3.0?

    The storage and handling requirements for the Xario 200, V3.0 are not specified.