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Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A (Aquilion Multi)

by Toshiba America Medical Systems, In.C

510(k) K990134

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 NumberK990134 Date19 Mar 1999ClearedStatusActive

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  • Withdrawn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, 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.

This device is a System, X-ray, Tomography, Computed upgrade kit designed to modify the Aquilion CT Scanner (TSX-101A) for multi-slice imaging. It incorporates multiple solid-state detectors to simultaneously acquire high-resolution axial slices, enhancing scan speed and reducing motion artifacts in anatomical imaging.

The kit is installed on an existing Aquilion CT Scanner (TSX-101A) to enable multi-slice axial data collection, reconstructing x-ray transmission data into cross-sectional images. Supplied as a non-sterile, reusable upgrade, it requires compatibility with the original scanner’s infrastructure. Authorized under FDA 510(k) clearance (K990134), it adheres to traditional review standards for computed tomography systems.

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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 is the primary purpose of the Multislice Upgrade Kit for the Aquilion CT Scanner (TSX-101A)?

    The kit is designed to upgrade an existing Aquilion CT Scanner (TSX-101A) to enable multi-slice imaging, allowing it to acquire multiple high-resolution axial slices simultaneously. This enhancement improves scan speed and reduces motion artifacts, making it useful for clearer anatomical imaging in clinical settings.

  • Is this upgrade kit sterile, and can it be reused after installation?

    No, the kit is non-sterile and is intended for reusable use on compatible Aquilion CT scanners. Since it is an upgrade component rather than a disposable medical device, it is not packaged in sterile conditions.

  • How is the upgrade kit installed, and what compatibility requirements exist?

    The kit is installed directly on an existing Aquilion CT Scanner (TSX-101A) to modify its imaging capabilities. It requires compatibility with the original scanner’s infrastructure, meaning it must be installed by trained personnel who ensure proper integration with the scanner’s existing hardware and software systems.

  • What regulatory pathway was followed for this upgrade kit’s approval?

    The kit was authorized through the FDA 510(k) clearance process under the classification JAK (Radiology), with a traditional review by the Radiology (RA) advisory committee. It was determined to be substantially equivalent to a legally marketed predicate device, as indicated by the clearance number K990134.