Skip to content

Aquilion Lightning (TSX-035A/2, V7.0)

by Toshibamedical Systems Corporation

510(k) K151833

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 NumberK151833 Date9 Oct 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1560-2016 FDA Class II initiated 12 Apr 2016

    Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.

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  • Withdrawn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

Other devices from Toshiba Medical Systems

See all devices from Toshiba Medical Systems →