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Aquilion ONE Vision, v7.0

by Toshibamedical Systems Corporation

510(k) K142465

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 NumberK142465 Date10 Mar 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0016-2016 FDA Class II initiated 8 May 2015

    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Aquilion ONE Vision, v7.0 is a computed tomography (CT) scanner system. It incorporates modifications including a new AIDR 3D selection (AIDR 3D Enhanced) for improved imaging capabilities.

The device is manufactured by Toshiba Medical Systems Corporation and is supplied in various models including TSX-301C/1, /2, /3, /4, /5, /6, /7, /8. It received FDA 510(k) clearance with K number K142465 on March 10, 2015, and is classified under product code JAK.

Other devices from Toshiba Medical Systems

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Questions

AI-generated answers, 25 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 Aquilion ONE Vision, v7.0 CT scanner system?

    The Aquilion ONE Vision, v7.0 is a computed tomography (CT) scanner system manufactured by Toshiba Medical Systems Corporation. It features AIDR 3D Enhanced technology for improved imaging capabilities.

  • What models are available for the Aquilion ONE Vision, v7.0?

    The device is supplied in various models including TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, offering different configurations to meet various clinical needs.

  • What is the regulatory status of the Aquilion ONE Vision, v7.0?

    The device received FDA 510(k) clearance with K number K142465 on March 10, 2015, and is classified under product code JAK. It was determined to be substantially equivalent to predicate devices.

  • What are the key imaging improvements in the Aquilion ONE Vision, v7.0?

    The system incorporates AIDR 3D selection (AIDR 3D Enhanced) which provides improved imaging capabilities compared to previous versions, enhancing diagnostic image quality.