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Aquilion Lightning, TSX-036A/1, V8.4

by Toshibamedical Systems Corporation

510(k) K170019

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 · Traditional NumberK170019 Date2 Feb 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1719-2020 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.

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  • Withdrawn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, 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 Aquilion Lightning, TSX-036A/1, V8.4 is a System, X-ray, Tomography, Computed, as classified under product code JAK. It is an 80-row CT system intended to acquire and display cross-sectional volumes of the whole body, including the head.

This device was cleared via the FDA 510(k) process under submission K170019, with a decision of Substantially Equivalent rendered on 2017-02-02. It is classified as Class II with Special Controls and was submitted by Toshiba Medical Systems Corporation. The device is used in radiology settings for diagnostic imaging.

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