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Aquilion LB Movement Base Kit

by Toshiba America Medical Systems, In.C

510(k) K111633

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK111633 Date25 Aug 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 26 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 LB Movement Base Kit is an optional gantry-mounted accessory designed for the Aquilion LB CT Scanner. It replaces the standard patient couch with a multipurpose patient handling system that enables longitudinal z-axis movement of the gantry. This allows for axial and helical image acquisition while the patient remains stationary.

This device is supplied by Toshiba America Medical Systems, Inc. and has received FDA 510(k) clearance. It is intended to be used as an optional gantry moving base that allows for the removal of a dedicated CT patient couch.

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Questions

AI-generated answers, 26 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 Aquilion LB Movement Base Kit?

    This accessory is designed to replace the standard patient couch on the Aquilion LB CT Scanner. It functions as a multipurpose patient handling system that enables longitudinal z-axis movement of the gantry, allowing for axial and helical image acquisition while the patient remains stationary.

  • Is the Aquilion LB Movement Base Kit compatible with all CT scanners?

    No, this device is specifically engineered as an optional gantry-mounted accessory for the Aquilion LB CT Scanner. It is intended to facilitate the removal of the dedicated CT patient couch for specific imaging workflows.

  • What is the regulatory status of this device?

    The Aquilion LB Movement Base Kit has received FDA 510(k) clearance under the number K111633. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.