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Aquilion Premium

by Toshiba Medical Systems Corporation, Japan

510(k) K120546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK120546 Date13 Jun 2012ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1721-2020 FDA Class II initiated 25 Mar 2019

    Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

    • Terminated Z-0015-2016 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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Aquilion Premium is a computed tomography (CT) system designed for medical imaging. It is used to acquire cross-sectional images of the body for diagnostic purposes. The device operates using X-ray technology and detector systems to produce detailed tomographic views.

The device is supplied by Toshiba Medical Systems Corporation, Japan, and was the subject of a premarket notification (510(k)) under number K120546. It is classified under product code JAK and reviewed by the Radiology advisory committee. The system is intended for use in clinical settings and is subject to regulatory evaluation for substantial equivalence.

Other devices from Toshiba Medical Systems Corporation, Japan

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Questions

AI-generated answers, 1 Oct 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 PREMIUM used for?

    It is a computed tomography (CT) system designed to acquire cross-sectional images of the body for diagnostic purposes. It uses X-ray technology and detector systems to produce detailed tomographic views.

  • Who manufactures the AQUILION PREMIUM?

    The device is manufactured and supplied by Toshiba Medical Systems Corporation, based in Japan, with administrative correspondence directed to their Tustin, CA office.

  • Is the AQUILION PREMIUM a single-use or reusable device?

    As a CT scanner, the AQUILION PREMIUM is a large, fixed medical imaging system intended for repeated clinical use in healthcare facilities. It is not a disposable or single-use device.

  • What regulatory pathway did the AQUILION PREMIUM follow?

    The device went through the FDA premarket notification (510(k)) process under number K120546. It was classified under product code JAK and reviewed by the Radiology advisory committee, with a determination of substantial equivalence.